Join Us

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role can be remote with preferably on the East Coast.

We are growing our Clinical team and are seeking a Pharmacovigilance-Safety Physician to join our team. Reporting to our VP of Clinical Development Operations and directly supporting the CMO, you will provide medical expertise on safety and pharmacovigilance (PV) on a global level for our clinical programs. In this role you will oversee the review, analysis, and approval of Individual Case Safety Reports (ICSR) and Periodic Reports for investigational programs. Additionally, you will maintain active pharmacovigilance oversight including safety surveillance, benefit-risk assessment, signal detection, and will provide safety/medical input for review of risk management. In this role you will lead monthly safety reviews in collaboration with the clinical development & operations team and support PV compliance, regulatory inspections and audits for Pharmacovigilance. In tandem you will lead the preparation, facilitation, and documentation of safety governance meetings. This is an excellent time to join TCR² as we embark on pivotal stage for our gavo-cel program and expand our clinical pipeline.

Responsibilities:

• Review and communicate safety data- trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue)
• Review and proactively assess potential issues that could be lead to an urgent safety measure or restriction in clinical development (including, but not limited to, premature termination or suspension of a trial). In these cases, provide recommendations for review and approval
• Perform medical review for ICSRs and Analyses of Similar Events (AOSE) in the global safety database and perform weekly review of safety data to ensure no serious adverse event has been inadvertently missed
• Contribute to the safety section of protocol synopses, study protocols, INDs, DSURs, PBRERs, CSRs, BLA, etc.
• Develops risk management strategy for each drug candidate and contributes to development strategy, including elements that require strategic cross-functional input and alignment
• Ensures that DSPV timelines for medical review are followed by providing oversight and collaborating with the medical reviewers at the CRO
• Provides medical input to decisions related to any recalls of clinical supplies

Requirements:

• Board Certified (US) MD with 8+ years’ experience in drug safety and pharmacovigilance
• Extensive experience in Case Safety Reports (ICSR), safety surveillance, benefit-risk assessment, signal detection, and risk management strategies
• Strong understanding of the use of medical terminology and of drug-names in multiple nations and environments
• Proficiency in Argus, Microsoft Office Suite (Word, Excel) and databases.
• Knowledge of and experience in cell and gene therapy is a plus

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD This role can be based either in Cambridge, MA or remotely within the East Coast. 

We are looking for a Director, Clinical Quality Assurance (GCP) to join our growing Quality Assurance department to provide quality oversight for our clinical trials. You will report to our US Quality Director and work closely with Clinical Operations, our Contract Research Organizations, Medical Affairs and Regulatory, as needed. As the Director, Clinical QA Systems you will be primarily responsible for developing, improving and maintaining Phase Appropriate Quality processes and procedures supporting Good Clinical Practice (GCP).This will role will be instrumental at preparing for and guiding us into pivotal trial. 

Responsibilities:

• Serve as the primary contact in QA for the oversight of Clinical Studies in the US and Canada to ensure compliance with all GCP’s from collection, labeling, distribution and site qualification to ensure compliance with all Regulatory requirements in the country the study is conducted
• Establish and maintain phase appropriate Quality Systems to support clinical studies. (including pharmacovigilance activities?). Implement (or assist with) GXP-compliant policies and procedures that are consistent, robust and integrated into the TCR2 Quality Management System
• Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation
• Plan, oversee/perform and follow-up audits of CROs, external laboratories, clinical trial sites
• Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies
• Collaborate with cross-functional management, including the Head of Clinical, Medical Affairs, Regulatory Affairs, and Information Technology to drive clinical process improvements and alignments

Requirements:

• BS or MS preferred with 8+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GCP Compliance
• Thorough understanding of clinical drug development, GCP, and familiarity with regulatory (FDA, Health Canada, and other global regulations) requirements for the conduct of clinical trials, including investigator-initiated studies
• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• The ability to represent QA cross-functionally and globally; to apply understanding of the team’s place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
• GCP Quality Assurance registration/certification preferred

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role is based in Cambridge, Massachusetts, and relocation is available if desired. This role will offer hybrid work flexibility. 

We are growing rapidly and are looking for a Sr. Manager, Microsoft 365 Solutions Architect as we expand our IT team. You will report to our VP of IT and work closely with various functions within TCR². Your main objective will be designing, deploying, and maintaining Microsoft Office 365 with an emphasis on SharePoint Online, Teams, Onedrive, & Power Platforms to build business solutions.This is a fantastic opportunity to directly shape the strategy and innovation of IT as we scale our organization. If this sounds exciting, we want to hear from you! 

Responsibilities:

• Implementation, maintenance, and support of Microsoft 365 business solutions, to include but not limited to SharePoint, Power Automate, Power Apps, Teams, and any related technologies the organization
• Utilizes advanced skill sets in SharePoint development and administration (e.g. site collection libraries, lists, custom forms, web parts, dashboards, and development of custom workflows, etc.)
• Provide migration planning and assistance from various collaboration platforms utilizing hybrid configurations, 3rd party tools and/or Microsoft On Boarding Services
• Manage new initiatives i.e. Intranet, Microsoft power apps for various workflows for onboardings & offboardings
• New site creations, Access requests, Issue resolution
• Prepare training material and perform trainings to increase the adoption of the platform
• Establish governance around Sharepoint / Teams technologies
• Performing maintenance of the SharePoint platform, servers, and intranet
• Partners with project sponsors and business users to understand solution requirements and needs
• Responsible for build of O365 development environment used for staging and testing potential new capabilities and production changes
• Defines and documents the solution designs including designing required software components, integration data access and platform

Requirements:

• BS. degree or equivalent experience
• 10+ years of experience with SharePoint technologies, including SharePoint Designer, Windows SharePoint Services, Office 365, SharePoint Server 2016 and SharePoint Online, and Web services
• Demonstrates in-depth, technical SharePoint 2013/2016/2019, MS Teams, Power BI, Power Automate, Power Shell, SQL server and M365 subject matter expertise
• Proficiency with tools for SharePoint configuration and customization, including SharePoint Designer, Napa & Windows PowerShell
• Professional certifications
• Exposure or experience with Data Loss Prevention (DLP) or Azure Information Protection (AIP)
• Experience with Microsoft Teams, collaboration solutions and workflow automation

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role is based in Cambridge, Massachusetts, and relocation is available if desired. This role will offer hybrid work flexibility. 

We are looking for an hands on Director, IT Business Partner G&A to join our growing IT team. Reporting to the Vice President of Technology, you will proactively engage throughout the organization to enable IT solutions that advance company objectives through systems and business process optimization.  The overall goal will be to leverage applications, vendors, and business processes to deliver effective solutions and drive IT operational excellence.

Your main objective is to be a trusted business partner of various G&A functions ( Finance, Legal, HR, Facilities ) and either enhance or implement new capabilities, systems or processes. The ideal candidate will be an experienced digital technology leader with in-depth understanding of all aspects of G&A processes, specifically HR/Finance, products, and associated technologies.

Responsibilities:

• Partner with G&A in developing the G&A technology portfolio, including design, architecture, implementation, security, and compliance of systems and applications
• Develop and lead G&A ‘s systems roadmap and digital strategy to scale programs, create capacity within program teams, and solve user experience challenges
• Familiarity with common enterprise systems and the ability to continuously learn to keep up with emerging trends in IT and cloud-based solutions will also enable deeper technical discussions and better decision-making.
• Work with all business functions to ensure compliance with Sarbanes Oxley IT General Controls (ITGC) & Audits
• Manage request intake and drive prioritization with your business partners
• Ensure compliance to change control and SDLC procedures
• Responsible for vendor management, including product and vendor evaluation, contract negotiation, supplier relationship management, and consulting management
• Analyze and report metrics on G&A systems activities in support of strategic decision-making initiatives and for ongoing measurement and continual improvement
• Aligning with TCR²  goals, provide strategic, forward-looking vision when designing solutions to strengthen capabilities, and future integration opportunities through the development of clear strategic technology roadmaps and scalable application support
• Execute software implementation, process redesign and ERP/Financial Systems projects
• Develop and own the enterprise applications IT portfolio of services and projects while managing associated budgets and support

Requirements:

• BS/BA degree in relevant discipline with at least 12+ years of industry experience in a biotech/pharma group
• Experience in G&A technology, digital solutions, employee experience, or customer-facing technology environment
• 10+ years of ERP/HRIS/Legal platform management experience
• Experience utilizing SaaS technology
• Experience creating requests for proposal (RFPs) and statements of work (SoWs), vetting solutions, and managing technology and vendor relationships
• Demonstrated leadership qualities and partnering skills
• Excellent organization, communication, and time management skills
• Work closely and effectively with all applicable stakeholders
• GMP manufacturing facility operations, network and Infrastructure preferred
• Strong compliance knowledge including SOX, GxPs, Sunshine Act, Global Data Privacy etc.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role is based in Cambridge, Massachusetts, and relocation is available if desired. This role will offer hybrid work flexibility. 

We are looking for a Director of IT Operations & Cyber Security to join our growing IT team. You will report to our VP of IT and work closely with the all functions within TCR².

Your main objective is to Deliver all operational services to meet expectations as measured by service level agreements in production support operations, IT security operations maintaining GxP compliance.

Responsibilities:

• Lead and maintain the day-to-day operations of on-prem and Cloud based infrastructure including switches, servers, wireless networks, firewalls, backup, storage, and telephone systems
• Assess current network infrastructure and make recommendations for improvement
• Accountable for Cyber Security Governance, systems, projects, vulnerability remediations, patch management, anti-virus monitoring and security policies. Coordinate Penetration Tests, Anti-Phishing campaigns, Single Sign-On. Security Awareness Trainings, create policies, continuously monitoring for threats and develop Incident response / mitigation strategy
• Develop and lead implementation plans for the infrastructure based on business requirements and IT strategies. Manages the benchmarking, analysis and recommendations for the improvement of the IT infrastructure and IT systems.
• Actively monitor and take pro-active/preventative action on IT security, GxP and regulatory compliance. Identify and manage risk related to systems nearing end of life or maximum capacity
• Manage external managed service providers in achievement of Infrastructure Operations service level agreements, key performance indicators, and best practices in IT architecture, GxP compliance, and IT production operations support
• Develop technical documentation, policies and procedures for information technology systems and applications. Develop and execute GxP documentation related to infrastructure systems where applicable
• Implement IT strategies and priorities for the Infrastructure Operations function to deliver on Company and/or IT goals and objectives
• Administration of MS Active Directory, MS server’s infrastructure (On-Prem/Azure), GPOs, NPS and variety of MS Domain services
• Own infrastructure disaster recovery planning, documentation, implementation and testing for all platforms. Maintain backups and perform regular testing in compliance with the backup policy

Requirements:

• Bachelor’s degree in Computer Science, or 10+years in IT Operations, 5+ years’ experience in leading an Infrastructure Operations team, Network administration, Active Directory, Group policy administration experience
• 5+years information security systems administration, supporting infrastructure systems hosting GxP applications, AWS / Azure experience
• Demonstrated depth of technology knowledge across multiple areas including prior experience in public cloud environments
• Experience developing policies and procedures to support operations
• Work closely and effectively with all applicable stakeholders
• GMP manufacturing facility operations, network and Infrastructure preferred
• Small to mid size biotech/pharma experience preferred

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role is based in Cambridge, Massachusetts, and relocation is available if desired. This role will offer hybrid work flexibility. 

We are looking for a Director, IT Business Partner of R&D, CMC & Clinical to join our growing IT team. You will report to our VP of IT and work closely with various functions within TCR².

Your main objective is to be a trusted business partner of R&D, CMC & Clinical functions & lead the delivery of the roadmap and ensures effective adoption of new solutions.

Responsibilities:

• Partner with our business stakeholders to align our digital transformation strategy and technology innovations roadmap to our R&D, CMC & Clinical business strategic objectives
• Apply knowledge of the pharmaceutical industry, maintains awareness of the competitive environment, and exhibits knowledge seeking and sharing best practices
• Serve as IT technical leader, providing guidance on new technologies and support for those technologies
• Develop or oversee creation and maintenance of design documents, SOPs, test scripts, user acceptance testing, user documentation, production support documentation, and other relevant deliverables for various IT systems
• Mobilize cross-functional project teams with members from Manufacturing, Quality, Planning and Regulatory to support CMC strategy
• Create strong relationships with team members and act as a key point person for Operations team members for project status communications, issue identification, and scope change management
• Vendor management experience including vendor evaluation / selection, due diligence, contracting, and performance management
• Robust project management experience in an international, team-oriented cross-functional environment. Managed project teams of varying size and resource mix / skill sets

Requirements:

• 15+ years of experience implementing and supporting various systems across R&D, CMC & Clinical functions
• Work closely and effectively with all applicable stakeholders
• Strong work ethic, with a proven track record in successfully achieving goals
• Exceptional skills at analyzing and navigating complex operational ecosystems, and maturity in managing inter-organizational dynamics
• GMP manufacturing facility experience required
• Small to mid size Life Science experience preferred

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD

TCR2 has embarked on establishing a cGMP manufacturing operations to provide manufacturing capacity for Phase 1 and Phase 2 operations, and beyond, for the TRuCTM T cell platform. We are looking for a Sr. Quality Assurance Associate who will support quality operations under the Quality Management System environment including product and batch record review, tracking training and deviations, change management, equipment validation,  and assisting with documentation control activities. In addition, the Sr. Quality Assurance Associate will support research operating procedure development, document control, and tracking training for the non-GMP departments.

Responsibilities:

• Maintain quality supporting documentation to facilitate GMP production including tech transfers and equipment qualification/validation at CMOs
• Perform review of manufacturing records and perform batch release for clinical lots.
• Manage Quality Change Control projects
• Review Change Control records impacting T cell therapy product and provide QA support for other changes
• Provide investigational support for deviations for the manufacture, testing, and shipping of raw materials or drug product
• Write and revise quality SOPs and associated documentation to support GMP production
• Support the quality vendor approval for suppliers, contractors and service providers, assist with external audits
• Conduct training for GMP and GDP processing
• Perform deviation review and implementation of CAPA to improve product quality
• Liaison with UK Quality department on quality related issues and provide support as needed

Requirements:

• Bachelor’s degree in the biological sciences or related field
• Minimum of 5 years GMP experience in a biotech, or biologics operation, or equivalent education/work experience
• Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS
• Prior experience in a quality function (quality assurance or quality control), preferably in a commercial environment
• Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards, preferably gained from working in a manufacturing or QC environment
• Good interpersonal, verbal and written communication skills
• Comfortable in a fast-paced small company environment with minimal direction
• External auditing experience preferred

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role is based in either Cambridge, Massachusetts or the Rockville, MD area, and relocation is available if desired.

We are looking for an Associate Director of Quality Control operations to join our growing Quality Control team. You will report to our VP of Quality and work closely with the Analytical Development, External Manufacturing, Process Development, Regulatory, and Quality Assurance teams.

Your main objective will be to optimize release and stability testing across our network of CDMOs and CTOs to enable timely and successful manufacture of lentiviral vector and T cell manufacturing for ongoing clinical trials and new programs. Your primary responsibilities will include oversight of release testing, critical reagent management, stability, and change control ownership; as well as ensuring test method comparability and harmonization. Additional activities include participation in the evaluation of new technologies, and support of the technology transfer to either our manufacturing group located in the US or additional CDMO/CTOs. The position represents an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment.

Responsibilities:

• Build and provide hands-on leadership to a small team of QC Managers and Associates
• Work with internal CMC stakeholders and contract manufacturing and testing organizations to implement and ensure execution of method transfers, qualifications, and release testing
• Initiate and assess change controls as needed, particularly focusing on gap remediation as well as optimization and harmonization of testing policies, procedures, and practices
• Design and write protocols for stability testing, and perform corresponding data analysis and stability assessments in collaboration with manufacturing and process development
• Write analytical testing sections of regulatory filings, supporting documentation, and contribute to the testing strategy
• Manage product release testing at multiple CDMOs, including investigation of OOS, OOT, and anomalous results. Investigation of deviations and oversight of CAPAs at CDMOs.
• Ensure compliance with regulatory guidance and consistency across multiple CDMOs.
• Oversee analytical method qualification, and ensure appropriate critical reagent management at CDMOs and CTOs.
• Work closely and effectively with all applicable stakeholders to ensure appropriate implementation of analytical methods transferred from TCR2.

 Requirements:

• B.S. in biochemistry, chemical engineering, or related discipline with 10+ years relevant industry experience, or M.S. with 8+ years experience.
• Analytical method and quality control experience in cell and/or gene therapy strongly preferred.
• Industry experience in quality control, including a proven track record of managing high performing quality control teams; some remote/third party management highly preferred.
• Experience with U.S. regulatory expectations and authorship of CTD sections.
• Experience with method qualification and/or validation and assay transfer.  Experience with qPCR, ddPCR, ELISA, and/or cell-based assays preferred. Experience with flow cytometry a plus.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a manufacturing facility in Rockville, MD. This role is based in either Cambridge, Massachusetts or the Rockville, MD area, and relocation is available if desired.

We are looking for an Associate Director of Quality Control operations to join our growing Quality Control team. You will report to our VP of Quality and work closely with the Analytical Development, External Manufacturing, Process Development, Regulatory, and Quality Assurance teams.

Your main objective will be to optimize release and stability testing across our network of CDMOs and CTOs to enable timely and successful manufacture of lentiviral vector and T cell manufacturing for ongoing clinical trials and new programs. Your primary responsibilities will include oversight of release testing, critical reagent management, stability, and change control ownership; as well as ensuring test method comparability and harmonization. Additional activities include participation in the evaluation of new technologies, and support of the technology transfer to either our manufacturing group located in the US or additional CDMO/CTOs. The position represents an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment.

Responsibilities:

• Build and provide hands-on leadership to a small team of QC Managers and Associates
• Work with internal CMC stakeholders and contract manufacturing and testing organizations to implement and ensure execution of method transfers, qualifications, and release testing
• Initiate and assess change controls as needed, particularly focusing on gap remediation as well as optimization and harmonization of testing policies, procedures, and practices
• Design and write protocols for stability testing, and perform corresponding data analysis and stability assessments in collaboration with manufacturing and process development
• Write analytical testing sections of regulatory filings, supporting documentation, and contribute to the testing strategy
• Manage product release testing at multiple CDMOs, including investigation of OOS, OOT, and anomalous results. Investigation of deviations and oversight of CAPAs at CDMOs.
• Ensure compliance with regulatory guidance and consistency across multiple CDMOs.
• Oversee analytical method qualification, and ensure appropriate critical reagent management at CDMOs and CTOs.
• Work closely and effectively with all applicable stakeholders to ensure appropriate implementation of analytical methods transferred from TCR2.

 Requirements:

• B.S. in biochemistry, chemical engineering, or related discipline with 10+ years relevant industry experience, or M.S. with 8+ years experience.
• Analytical method and quality control experience in cell and/or gene therapy strongly preferred.
• Industry experience in quality control, including a proven track record of managing high performing quality control teams; some remote/third party management highly preferred.
• Experience with U.S. regulatory expectations and authorship of CTD sections.
• Experience with method qualification and/or validation and assay transfer.  Experience with qPCR, ddPCR, ELISA, and/or cell-based assays preferred. Experience with flow cytometry a plus.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

Manager of Process and Analytical Method Quality Assurance

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210 for solid tumors and TC-110 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes. We are headquartered in Cambridge, Massachusetts and are building out a manufacturing facility in Rockville, MD.  This global role can be based in either Cambridge or Rockville.

We are looking for a Manager of Process and Analytical Method Quality Assurance to provide Quality oversight and support to technology and method transfer, validation, and continuous improvement. 

You will report to the Director/Head of Quality Engineering and Validation and collaborate closely with our Process and Analytical Development Team as well as multiple internal and external manufacturing and testing partners.  This role is critical to the optimization and harmonization of our cell therapy supply network, and also in preparing our company for success in Phase 2/3-Pivotal trials and beyond.  This is a unique opportunity to join a growing team and build a great legacy.

Responsibilities: 

• Establish and oversee phase-appropriate, risk-based validation and qualification of manufacturing processes and analytical test methods at CDMOs and CTOs.
• Develop, maintain, and improve validation policies, master plans, and SOPs that reflect company and industry best practices
• Provide QA Validation support for technology and method transfers between partner companies, Process and Analytical Development, and internal manufacturing sites
• Perform risk assessments, gap assessments for analytical methods and aim to enhance compliance and robustness
• Champion continuous improvement of processes and methods, as well as the supporting Quality Management Systems; through robust analysis of development history and performance.
• Support FDA and other regulatory agency inspections, develop CMC sections of regulatory applications, with leadership oversight
• Other duties as assigned.

Requirements: 

• Bachelors’ Degree in Biochemistry, Molecular Biology, or related field, MS preferred
• Experience in clinical-stage cGMP environments
• Track record of successful process and/or method validation and continuous improvement
• Knowledge and experience with qPCR, ddPCR, ELISA, and/or cell-based assays highly preferred
• Effective interpersonal skills, project management and organizational skills.
• Superior technical writing skills
• Proven strong and visible leadership with the ability to influence other functions within the organization
• Experience in managing scientists/engineers in a fast paced, challenging environment. It is essential that this leader creates an engaging workplace with a strong focus on strategy and developing and empowering people
• Strong knowledge of ICH guidelines and QbD principles applicable to a manufacturing environment, with successful application experience
• Desire to work in a fast-paced growing company!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210 for solid tumors and TC-510 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes.

We are headquartered in Cambridge, Massachusetts and are building an internal manufacturing facility in Rockville, MD. This remote-capable role is based in Cambridge, Massachusetts.

We are looking for a hands-on Quality Control (QC) Manager to work directly with our critical external testing laboratory partners and drive consistent, flawless execution of analytical testing associated with our autologous cell therapies.  You will report to the Associate Director of External Quality Control and collaborate closely with our Analytical Development, Quality Assurance, Manufacturing, and Supply Chain teams on clinical pipeline programs to help prepare the company for Phase 2-3/Pivotal trials and beyond.  You will have the opportunity to become a subject matter expert with leading edge technology while gaining valuable operational and partnership management skills.  This position is also a great opportunity to have a direct impact on patients. If you thrive in a highly collaborative, fast-paced environment and are looking for a role where you’re given ownership and accountability to get results and make an impact, we want to hear from you.

Responsibilities:

• Take an active role in the oversight and continuous improvement of partner company QC operations, particularly analytical testing.
• Review and evaluate test data, COA/COCs, and other test information to support the release of drug product for clinical use
• Drive successful method transfer, validation, optimization, and harmonization across our entire network
• Lead investigation and resolution of issues causing out-of-specification or out-of-trend results
• Monitor, analyze, trend, and report (including Quality Management Review) test results.
• Participate in and/or lead improvements to analytical testing strategy.
• Participate in audits of laboratories as a subject matter expert
• Support development and maintenance of quality agreements.
• Develop, oversee, and conduct training programs as directed.

Requirements:

• Masters degree or PhD in Biochemistry, Micro/Molecular Biology, or related field.
• Minimum of 5 years experience in QC or Analytical Development role in a biotech or biologics operation with progressively increasing responsibility in a lead capacity.
• Proven experience in various analytical techniques commonly used for cell and gene therapy testing, including flow cytometry, ELISAs, qPCR/ddPCR, and cell-based assays. 
• Experience with transfer, qualification, and validation of methods
• Strong technical writing skills, specifically with effective protocol, report, and investigation document experience
• Excellent communication, collaboration, partnering, and influencing skills required
• Possess a flexible yet pragmatic approach to problem solving, be an adept negotiator and apply risk-based decisions
• At home in a results-driven, highly accountable collaborative environment where you can make a clear impact.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD

We are growing and looking for Process Development Co-Ops. You will have the opportunity to either work on with the T Cell Production team on the development of a robust and scalable manufacturing process.

This role is a unique opportunity to learn and advance your career development actively working with a close team in a fast-paced and highly collaborative environment. We are experiencing hyper-growth, we are looking at this as a long-term opportunity and real opportunity for conversion for students who are nearing graduation. 

 Responsibilities:

• Learn and utilize new skills to help develop T Cell Production processes including T cell isolation, enrichment, activation, transduction, expansion, and cryopreservation
• Learn the execution of key projects through both independent execution and collaboration with other team members
• Learn to generate data through well-defined and executed design of experiment studies, while organizing and prioritizing work to meet timelines

 Requirements:

• You are in a BS or MS program in biotechnology, immunology, cell biology or related discipline and 2 years of industry experience preferred
• You must have hands on technical experience with cell culture handling. Experience with in-vitro cell-based assays involving flow cytometry is preferred.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA. 

We are looking for an Associate Scientist to develop novel molecular assays to detect and quantify impurities in our drug product and process. This position will also participate in T Cell product characterization studies. You will report to our Scientist, Analytical Development and work closely with the T Cell Process Development team.

Your primary responsibilities will include research and development of assays to detect process-related impurities during the T Cell production process, and assay qualification. Authoring work instructions, protocols, reports, and presentations will be critical in this role. Additional activities could include improvement of existing assays and routine testing of samples throughout the T Cell production process, including the final product. This position represents an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment.

Responsibilities:

• Develop new analytical methods in-house and manage method development and/or custom reagent development at contract research organizations as necessary.
• Execute a variety of analytical methods, including cell-based assays, ELISAs, and flow cytometry.
• Analyze data, document results, and write corresponding technical reports for product characterization studies.
• Write protocols and reports for internal and/or regulatory use.
• Work closely and effectively with CMC stakeholders, including Process Development and Quality.
• This is a hands-on position requiring execution of laboratory experiments.

Requirements:

• M.S. in biochemistry, chemical engineering, or related discipline with 4+ years relevant industry experience, or B.S. with 5+ years relevant industry experience.
• Industry experience is required for this position.
• Experience with analytical assays required, with emphasis on cell and plate-based assays.
• Strong technical writing skills with industry experience writing technical protocols, reports, and procedures is required.
• Experience with flow cytometry, mammalian cell culture, and/or primary human cells a plus.
• Experience with statistical analysis software, e.g. JMP, is a plus.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail.
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA. 

We are looking for an Associate Director to join the Analytical Development group as a CMC Analytical Product lead for our gavo-cel product and Regulatory submission SME. You will report to our head of Analytical Development and work closely with the Process Development, Regulatory, and Translational Research teams.

Responsibilities as a CMC analytical product lead will include a variety of activities as the product expert, including authorship of regulatory submissions and supporting documents along with design, coordination, and execution of studies to better understand product attributes in support of regulatory filings and other CMC activities. You will additionally be responsible for cross-functional collaboration to support successful manufacturing and testing of T Cell drug products and lentiviral vectors for clinical trials. Additional activities include participation in the evaluation of new technologies, and support of the technology transfer to internal and external manufacturing partners. The position represents an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment.

Responsibilities:

• As gavo-cel analytical product lead, contribute to and execute the analytical strategy through planning and authorship CMC sections of regulatory filings and supporting documents.
• As T Cell drug product SME, evaluate, plan, and document studies for product understanding.
• Assist junior team members with experimental design, data analysis, interpretation, troubleshooting, and technical report authorship.
• Write protocols, reports, policies, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use.
• Work closely and effectively with our internal manufacturing group and/or CMOs to ensure appropriate implementation of analytical methods transferred from TCR2.
• Provide direction, management, and mentorship for junior team members.
• This is a Cambridge, Massachusetts based position requiring supervision of junior laboratory staff and occasional troubleshooting or other laboratory oversight.

Requirements:

• Ph.D. in biochemistry, chemical engineering, or related discipline with at least 6 years of relevant industry experience, M.S. with 10+ years relevant industry experience, or B.S. with 12+ years relevant industry experience.
• Strong technical writing skills with industry experience writing regulatory documents, including CMC sections of INDs, BLA, and/or MAAs. Additional experience writing technical protocols, reports, and procedures required.
• Experience in cell and gene therapy strongly preferred; experience with analytical comparability a plus.
• Experience with analytical assay development required, with emphasis on flow cytometry.
• Experience with qPCR, ddPCR, ELISA, and/or cell-based assays a plus.
• Experience with method qualification and/or validation.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD

We are looking for a Principal Scientist/Associate Director to drive method development for our TRuC T Cells. You will report to our head of Analytical Development and work closely with the Regulatory and T Cell Process Development teams.

The successful candidate will join the Analytical Development Team to drive method development for T Cell release testing and characterization. Primary responsibilities include design of studies for method development and qualification, authorship of technical protocols and reports, coordination of testing, and troubleshooting as needed. Additional activities include support of method transfer to internal and external manufacturing partners. The position represents an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment.

Responsibilities:

• Manage a team focused on T Cell method development, including provision of mentorship, guideance, and hiring of new team members.
• Provide relevant updates to CMC leadership on T Cell analytical methods, and contribute to CMC strategy for release testing and characterization of T Cell drug product.
• Manage execution of analytical methods to support assay development and product understanding for lentiviral vectors and T Cells.
• Design experiments, assist with data analysis, interpretation and troubleshooting and write corresponding technical reports for method development and product understanding studies.
• Coordinate and schedule routine testing for junior group members and prioritize work to meet timelines.
• Write protocols and operating procedures for technology transfer and internal use.
• Work closely and effectively with our internal manufacturing group and/or CMOs for technology transfer and support.
• This position requires some in-person attendance for oversight of laboratory work, troubleshooting, and team leadership. 

Requirements:

• Ph.D. in biochemistry, chemical engineering, or related discipline with at least 4 years of relevant industry experience, M.S. with 10+ years relevant industry experience, or B.S. with 12+ years relevant industry experience.
• Strong technical writing skills with industry experience writing technical protocols, reports, and procedures required.
• Experience with analytical assay development required, with emphasis on flow cytometry and plate-based bioassays.
• Experience with method qualification and/or validation a plus.
• Experience with flow cytometry and cell-based assays required. Experience with primary T cells a plus.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD

We are looking for an Associate Scientist to perform testing of cellular drug products using complex bioassays and participate in T Cell product characterization studies. You will report to our Principal Scientist, Analytical Development and work closely with the Regulatory and T Cell Process Development teams.

Your primary responsibilities will include testing of manufactured T Cells, and characterization of engineered T Cells for product and attribute understanding. Additional activities could include evaluation of new technologies, improving existing assays, and authorship of regulatory documents. The position represents an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment.

Responsibilities:

• Execute a variety of analytical methods, including cell based assays, ELISAs, and flow cytometry.
• Analyze data, document results, and write corresponding technical reports for product characterization studies.
• Write protocols and reports for internal and/or regulatory use.
• Work closely and effectively with CMC stakeholders, including Process Development, Regulatory, and Quality.
• This is a hands-on position requiring execution of laboratory experiments.

Requirements:

• M.S. in biochemistry, chemical engineering, or related discipline with 4+ years relevant industry experience, or B.S. with 5+ years relevant industry experience.
• Industry experience is required for this position.
• Experience with analytical assays required, with emphasis on cell and plate-based assays.
• Experience with flow cytometry, mammalian cell culture, and/or primary human cells a plus.
• Strong technical writing skills with industry experience writing technical protocols, reports, and procedures is required.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail.
• Team-based candidate interested in a fast-paced, exciting, start-up environment!

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD 

We are growing and hiring a Scientist/Sr. Scientist to join our Process Development team. You will report to our Associate Director of Vector Process Development and work closely across the Process Development group on the purification of lentiviral vectors and development of a robust and scalable manufacturing process. The role is a unique opportunity for you to advance your career development, actively working with a close team in a fast-paced and highly collaborative environment.

Responsibilities: 

• Help develop, optimize, and scale downstream purification processes for viral vectors
• Optimize parameters through well-defined design of experiment studies
• Analyze and document scientific results for IND enabling study content
• Mentor and manage associates during execution of internal and external tasks
• Write protocols and reports to support technology transfers from process development to manufacturing
• Organize and prioritize work to meet timelines with ability to execute on multiple projects
• Represent TCR2 at scientific presentations and meetings

Requirements: 

• MS with 5 years or Ph.D. with 3 years industry experience with degree in chemical engineering, biochemical engineering, or related discipline
• Technical experience with purification applications, including extensive knowledge of filtration and chromatography applications is required
• Additional experience with formulation and fill/finish activities is preferred
• Experience with tech transfer and GMP manufacturing systems is preferred
• Experience leading small teams in lab experimental execution is preferred
• Outstanding critical thinking and organizational skills, leadership, and attention to detail 
• Team-based candidate interested in a fast-paced, exciting, start-up environment! 

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. 

We are looking for a Research Associate/Sr. Research Associate to join the T Cell Process Development team to work on cutting edge TRuC T cell manufacturing process, and to support regulatory filings. You will report to our Senior Scientist, T Cell Process Development and work closely with the Analytical Development group and other teams as needed. This is an excellent opportunity for career development, working closely with experienced scientists in a fast-paced and highly collaborative environment to support the production and in vitro characterizations of novel autologous and allogeneic TRuC-T cells programs.

Responsibilities:

• Perform T cell isolation, enrichment, activation, transduction, expansion and cryopreservation utilizing functionally closed cell systems
• Perform in-vitro cellular assays involving flow cytometric, molecular and functional characterization of genetically engineered primary T cells
• Collaborate with the Analytical Development group in improving primary T-cells characterization
• Contribute to the development and production of TRuC™ T-cells for various pipeline programs and in-vivo animal studies
• Analyze results and document scientific results for IND enabling studies

Requirements:

• B.S./M.S. degree in immunology, cell biology or similar discipline with 2+ years of experience in biotech and/or Pharma
• Experience in analytical assay execution and development, particularly cell based toxicity assays is required and flow cytometry, ELISA, PCR is preferred 
• Experience working with lentiviral and transduction of human T cells along with functionally closed systems are highly desirable. If no experience this is an opportunity to learn!
• Excellent attention to detail and problem-solving skills, ability to analyze and interpret data.
• Must be a highly effective collaborator with strong written/verbal communication and interpersonal skills

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD

We are growing and hiring a Research Associate/Senior Research Associate (Dependent on experience) to join our Process Development team. You will report to a Senior Scientist on the team and work with the rest of the team for the purification of lentiviral vectors, and development of a robust and scalable manufacturing process.

This role is a unique opportunity for you learn and advance your career development actively working with a close team in a fast-paced and highly collaborative environment.

Responsibilities: 

• Utilize skills to help develop, optimize, and scale downstream purification operations for our viral vector process
• Lead key projects through both independent execution and collaboration with other team members
• Generate data through well-defined and executed design of experiment studies, while organizing and prioritizing work to meet timelines 
• Write protocols and reports to support executed work and technology transfers from process development to manufacturing
• Present executed work at scientific presentations and meetings

Requirements: 

• BS or MS in chemical engineering, biochemical engineering, or related discipline and at least 3 years of industry experience
• Technical experience with purification applications is required, including solid foundational knowledge of filtration and chromatography applications
• Additional experience with formulation and fill/finish activities is a plus
• Experience with tech transfer and GMP manufacturing systems is preferred
• Outstanding critical thinking and organizational skills, leadership, and attention to detail 
• Team-based candidate interested in a fast-paced, exciting, start-up environment! 

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD 

We are looking for a Principal Scientist to join the T Cell Process Development group to work on the late-stage development, characterization, and commercialization of novel autologous and allogeneic TRuC-T cell programs as well as support regulatory filings. Under minimal supervision, you will be expected to design, manage, and perform experiments, organizing, analyzing, and carefully documenting results, as well as communicate findings. This is an excellent opportunity for career development, working closely with the Viral Vector and Analytical Development groups leading a team of scientists and associates in a fast-paced and highly collaborative environment.

Responsibilities:

• Individually contributing and leading a team of 2-3 Scientists/ associates to establish small scale model(s) for T-cell Manufacturing.
• Lead the design and execution of process development studies to develop a thorough understanding of operating and performance parameters (Design space) for T cell manufacturing processes.
• Performs gap analysis and risk assessments to identify problems and deficiencies, as well as provide recommendations for studies and solutions to manufacturing process.
• Develops and leads strong collaborative relationships with internal and external groups. 
• Lead tech transfer activities for T-cell operations to manufacturing sites.
• Support the development of standard operating procedures, FMEA, batch records, and analytical sampling plans.
• Serve as Subject Matter Expert (SME) for operations for T-cell Manufacturing.

Requirements:

• M.S. or Ph.D. in Engineering, science or biology science.
• M.S. with 7+ years or Ph.D. with 4+ years of relevant industry experience. 
• Experience with process characterization, scale-up and/or technology transfer required.
• Experience using Design of Experiment (DOE) and statistical analysis using tools such as JMP.
• Familiarity with commercialization of cell-based therapeutics preferred.
• Experience with functionally closed systems preferred.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD

We are looking for a Senior Scientist to join the T Cell Process Development group to work on early stage process development of novel pipeline autologous and allogeneic TRuC-T cell programs as well as support regulatory filings. Under minimal supervision, you will be expected to design, manage, and perform experiments, organizing, analyzing, and carefully documenting results, as well as communicate findings. This is an excellent opportunity for career development, working closely with the Viral Vector and Analytical Development groups leading a team of associates in a fast-paced and highly collaborative environment.

Responsibilities:

• Evaluate, develop and implement functionally closed systems for T cell isolation, enrichment, activation, transduction, expansion and cryopreservation.
• Lead the design and execution of process development studies to support pre-IND / IND activities.
• Perform in-vitro cellular assays involving flow cytometric, molecular and functional characterization of genetically engineered primary T cells.
• Support production of TRuC™ T-cells for various pipeline programs and in-vivo animal studies.
• Analyze results and document scientific results for critical regulatory filings.
• Lead tech transfer activities for T-cell operations to manufacturing sites.
• Support the development of standard operating procedures, FMEA, batch records, and analytical sampling plans.
• Serve as Subject Matter Expert (SME) for operations for T-cell Manufacturing.

Requirements:

• M.S. or Ph.D. degree in Engineering, immunology, cell biology or similar discipline. 
• M.S. with 5+ years or Ph.D. with 2+ years of relevant industry experience.
• Experience in analytical assay execution and development, particularly flow cytometry, ELISA, and cell based functional assays.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail.
• Experience with functionally closed systems or early technology evaluations  highly desirable.
• Experience with cGMP manufacturing requirements preferred.
• Desire to build a scalable manufacturing process and be a part of a growing company.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD 

We are looking for a Scientist to join the T Cell Process Development group to work on the late-stage development, characterization, and commercialization of novel autologous and allogeneic TRuC-T cell programs as well as support regulatory filings. You will support / lead experimental design, execution, analysis, and reporting of experiments related to design space and process characterization activities for T-cell manufacturing. This is an excellent opportunity for career development, working closely with the Viral Vector and Analytical Development groups comprised of experienced scientists and associates in a fast-paced and highly collaborative environment.

Responsibilities:

• Support development of small-scale model(s) for T cell Manufacturing.
• Support / lead the design and execution of process development studies to develop a thorough understanding of operating and performance parameters (Design space) for T cell manufacturing processes.
• Perform in-vitro cellular assays involving flow cytometric, molecular and functional characterization of genetically engineered primary T cells.
• Perform gap analysis and risk assessments to identify problems and deficiencies, as well as provide recommendations for studies and solutions to manufacturing process. 
• Lead tech transfer activities for T-cell operations to manufacturing sites.
• Support the development of standard operating procedures, FMEA, batch records, and analytical sampling plans.
• Serve as Subject Matter Expert (SME) for operations for T-cell Manufacturing.
• Support regulatory agency filings.

Requirements:

• B.S., M.S. or Ph.D. in Engineering, science or biology science.
• B.S. with 6+ years or M.S. with 3+ years or Ph.D. with 1+ years of relevant industry experience. 
• Experience using Design of Experiment (DOE) and statistical analysis using tools such as JMP.
• Experience with process characterization, scale-up and/or technology transfer preferred.
• Familiarity with commercialization of cell-based therapeutics preferred.
• Experience with functionally closed systems preferred.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210 for solid tumors and TC-510 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes.

We are headquartered in Cambridge, Massachusetts and are building an internal manufacturing facility in Rockville, MD. This remote-capable role is based in Cambridge, Massachusetts.

We are looking for a hands-on Quality Manager to work directly with our critical external manufacturing and logistics partners and ensure phase-appropriate Quality oversight of production of our autologous cell therapies.  You will report to the Senior Director of QA and collaborate closely with our Manufacturing, Supply Chain, Process Development, and Regulatory Affairs teams on clinical pipeline programs to help prepare the company for Phase 2/Pivotal trials and beyond.  You will have the opportunity to lead Quality Change projects and implement supporting electronic systems.  This position is a great opportunity to help design and build strong sustainable quality systems that will grow along with the business. If you thrive in a highly collaborative, fast-paced environment and are looking for a role where you’re given ownership and accountability to get results and make an impact, we want to hear from you.

Responsibilities:

• Take an active role in the oversight and continuous improvement of both internal and partner company Quality Management Systems, including implementing systems, policies and procedures, and systemic changes.
• Promote and advance a Culture of Quality.
• Provide cross-functional Quality leadership and act as a subject matter expert on technical matters including qualification/validation, tech transfer, data integrity, quality and compliance.
• Actively participate in and/or lead major Change Control Projects
• Play an active leadership role in building out our Supplier Quality Management Program, and in applying the Vendor Qualification process.  This will include development and maintenance of quality agreements and vendor audits.
• Develop, oversee, and conduct training programs as directed, both in specific areas of expertise and general Quality topics.
• Establish key metrics for quality system monitoring and process improvement, report at Quality Management Reviews
• Perform final Quality Review to release drug product for clinical use.

Requirements:

• Bachelor’s degree in the biological sciences or related field.
• Minimum of 8 years GMP/Quality experience in a biotech or biologics operation with progressively increasing responsibility in a lead capacity.
• Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS. Electronic QMS experience preferred.
• Excellent communication, collaboration, partnering, and influencing skills required
• Possess a flexible yet pragmatic approach to problem solving, be an adept negotiator and apply risk-based decisions
• At home in a results-driven, highly accountable collaborative environment where you can make a clear impact.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD 

We are seeking a talented Senior Scientist/Principal Scientist with a strong background in cancer immunotherapy to support the advancement of TCR2’s pipeline of targeted TRuC T cell therapies. Reporting the Sr. Director of Pharmacology, you will possess hands-on expertise in the ex vivo isolation and immunoprofiling of tumor-infiltrating T cells from mouse models and will apply these skills to advance our understanding of TRuC T cell function and behavior as we select lead candidates. 

Responsibilities:

• Perform ex vivo assessments of tumor-infiltrarting TRuC T cell functionality and behavior using various technologies, including but not limited to flow cytometry, MSD, Luminex, IHC, Nanostring/RNA-seq
• Develop novel assays and explore new technologies for immunoprofiling of TRuC T cells
• Define the pharmacokinetic and pharmacodynamic properties of TRuC T cells by longitudinal analysis of TRuC T cell expansion, immunophenotype, biodistribution, gene expression profiling, and cytokine release
• Generate mechanistic and functional data to guide the selection of TRuC T cell lead candidates and identification of optimal enhancement strategies
• Serve as a member of cross-functional program teams and lead the design of ex vivo analysis endpoints for in vivo pharmacology studies
• Present research findings to internal and external audiences

Requirements:

• Ph.D.* in biology-related discipline with 1-2+ years of post-Ph.D. research experience, in adoptive T cell therapies or immunology
• Hands-on expertise with the functional profiling of T cells using flow cytometry (high dimensional/multiparameter), gene expression profiling (Nanostring, RNA-seq), IHC, and other technologies
• Experience with assessing the efficacy of immunotherapies in syngeneic and/or xenograft tumor models is highly desirable
• Well-versed in T cell therapy pharmacokinetic and pharmacodynamic ex vivo endpoints, including T cell expansion, persistence, biodistribution, cytokine release, and phenotype
• Excellent oral and written communication skills with experience leading the authorship of manuscripts; experience authoring regulatory documents a plus
• Keen attention to detail with excellent organizational and record-keeping skills

*Candidates without a Ph.D. may be considered if they have commensurate experience

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with A clinical manufacturing facility in Rockville, MD

We are looking for a Senior Research Associate / Associate Scientist to join the Translational Science team and assist in functionally characterizing patient-derived clinical samples through in vitro tissue culture assays. You will report to a Principal Scientist in Translational Sciences, and work closely with other experienced scientists in the Translational Sciences and R&D Teams to support clinical-level programs. Here, you will help characterize patient-derived T cell products using tissue culture-based assays and flow cytometry, as we search for early biomarkers and indications of an enhanced therapeutic response. This is a unique opportunity for career development where you will get the chance to work with patient samples in support of clinical-level programs, to gain immunological assay development experience, and to work in a fast-paced and highly collaborative environment.

Responsibilities:

• Establish/analyze cell-based functional assays to characterize patient samples, with a primary focus on tissue culture of T cells, ELISA, and/or flow cytometry.
• Follow and execute detailed in vitro assay standard protocols, under supervision if needed.
• Prepare data reports, properly document sample use, and maintain a detailed, accurate electronic laboratory notebook.
• Present results internally at team meetings, and contribute to scientific discussions.

 Requirements:

• B.S. or above in a biology-related science with 2+ years of lab based experience. Experience will determine level of role.
• Highly proficient in either tissue culture of T cells, ELISA assays, and/or flow cytometry sample preparation.
• Demonstrated ability to follow complex protocols and an interest in developing new skills.
• Detailed oriented with strong organizational and record-keeping skills.
• Basic data analysis skills with willingness to learn advanced analysis methods.
• Must be a strong team player with effective written/verbal communication skills.
• Proficiency using programs such as Excel, PowerPoint, GraphPad Prism (or similar), and FlowJo (or similar) for data entry, analysis, and presentations.
• This is a lab-based role, requiring the ability to work at a desk / lab bench, or on a computer, for prolonged periods of time.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD 

We are looking for a Scientist to join the Translational Science team and assist in functionally characterizing patient-derived clinical samples through in vitro tissue culture assays. You will report to a Senior Scientist in Translational Sciences, and work closely with other experienced scientists in the Translational Sciences and R&D Teams to support clinical-level programs. Here, you will help characterize clinical patient-derived T cell products, as we search for early biomarkers and indications of an enhanced therapeutic response. This is a unique opportunity for career development where you will get the chance to work with patient samples in support of clinical-level programs and to work in a fast-paced and highly collaborative environment.

Responsibilities:

• Establish/analyze cell-based functional assays to characterize patient samples. These assays will include (but are not limited to) flow cytometry, target cell killing, ELISA for cytokine production, and Nanostring transcriptional profiling.
• Follow and execute detailed in vitro assay standard protocols, and establish complex in vitro experiments.
• Prepare data reports, properly document clinical patient sample use, and maintain a detailed, accurate electronic laboratory notebook.
• Present results internally at team meetings, and contribute to scientific discussions.
• Evaluate emerging technologies and platforms to aid in defining and implementing the biomarker strategy in the context of early-stage clinical trials.
• Passage cell lines, handle primary cells, and other lab-based responsibilities to support Translational Sciences research.

 Requirements:

• B.S. or above in a biology-related science with 5+ years of relevant experience, or a PhD in a relevant field.
• Highly proficient in tissue culture, with demonstrated ability to follow complex tissue culture protocols, and a strong interest in developing new skills.
• Hands-on experience with assay development / qualification, preferably in assays of T cell function.
• Previous experience working with Incucyte systems a plus.
• Detailed oriented with strong organizational and record-keeping skills.
• Basic data analysis skills with willingness to learn advanced analysis methods.
• Must be a strong team player with effective written/verbal communication skills.
• Proficiency using programs such as Excel, PowerPoint, and GraphPad Prism (or similar) for data entry, analysis, and presentations.
• This is a lab-based role, requiring the ability to work at a desk / lab bench, or on a computer, for prolonged periods of time.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. The ideal candidate will be based in Cambridge, MA, but this role is open for remote work with travel as needed. 

Responsibilities:

• Oversee efforts to identify and manage CROs for clinical biomarker assays; qualify/validate assays at CROs, oversee proper clinical sample testing and data analyses to support clinical program(s)
• Collaborate closely with the clinical operations and process development teams to monitor clinical sample collection and testing
• Review and approve the qualification/validation reports, study/lab manuals, data packages to support publication/presentation and/or submission to regulatory agencies
• Support generating hypothesis from clinical biomarker data for patient selection and TRuC T cell platform characterization for better patient outcome
• Continuously evaluate new technologies for clinical immunomonitoring and T cell functional characterization and develop new strategies for data analysis to maintain TCR2 on the cutting edge of clinical research

Requirements:

• MS, Ph.D. preferred, in immunology or similar discipline with 6+ years of directly relevant experience with at least 3+ years in the field of Translational Research and/or Immuno-Oncology is highly desirable
• Demonstrated experience leading clinical biomarker assay qualification at CROs, data analysis, and MoA/translational research for immuo-oncology/cell therapy clinical trials
• Experience with bioanalytical assays, including assays of T cell function, multi-parametric flow cytometry, mass cytometry, multiplex IHC/IF assays, real-time PCR and next generation sequence analysis
• Experience with CDx development is highly desirable
• Highly effective collaboration, written/verbal communication, and interpersonal skills

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. 

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA with hybrid flexibility. 

We are looking for a Sr. Scientist in Translational Research to work on the development of TCR²’s clinical programs and pipeline. You will report to our Director of Translational Science and work closely with a team of experienced Scientists analyzing patient samples and generating key biomarker data to determine correlations associated with clinical outcomes. This is a great opportunity for a talented Scientist working on Immunology research (or similar) to advance your career working on a clinical stage cell therapy programs as we continue to advance our pipeline.

Responsibilities:

• Manage CROs for timely and accurately running patient samples and delivering data to support clinical program(s)
• Collaborate closely with the clinical operations and manufacturing teams to monitor clinical sample collection and testing
• Review study/lab manuals and SOPs/ROPs for proper sample analysis and data collection.
• Assist generating and evaluating key data packages to support publication/presentation and/or submission to regulatory agencies
• Work as a key member to translational sciences team for defining and implementing data driven biomarker strategies to support correlative analysis for better patient outcome

Requirements:

• Ph.D.(preferred) or equivalent industry experience in immunology or similar discipline with 3+ years of directly relevant experience with at least 2+ years in an industry setting
• Experience in handling CROs to manage and analyze clinical samples is required; experience with Immuno-Oncology and/or cell therapies is highly desirable
• Experience leading the development and validation of biomarker assays using a broad range of technologies including ligand binding immunoassays, assays of T cell function, multi-parametric flow cytometry, mass cytometry, multiplex IHC/IF assays, real-time PCR and next generation sequence analysis
• Experience in complex data analysis is plus
• Experience in handling and managing clinical samples and biomarker assays is a plus 
• Highly effective collaboration, written/verbal communication, and interpersonal skills

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product Gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA. 

We are hiring for a Research Associate/Sr. Research Associate role, dependent on experience, that will support the discovery, generation and characterization of antibodies, antibody fragments, and novel fusion proteins to propel our TRuC™ platform. You will report to a Principal Scientist in the Protein and Cell Sciences group, collaborating within that team and across the R&D organization. This is a unique opportunity for someone with prior experience and/or interest in protein chemistry to gain expertise in immune-oncology by supporting the pre-clinical discovery and development of antibodies and TRuC™ T-cell therapies.

Responsibilities:

• Protein expression in bacterial (E. coli) and mammalian tissue culture systems; protein purification by metal-affinity, ion exchange, immunoaffinity and size exclusion chromatography using an AKTA or similar FPLC system
• Analysis of protein samples, to include SDS-PAGE, Western-blotting, and protein interactions by ELISA, 1-3 color flow cytometry, MSD, and Octet (BLI) affinity measurement
• Assessment of antibody affinity, epitope binning, and epitope mapping using Octet or ELISA.
• Optimization and troubleshooting of protein expression and purification
• Development of antigen specific cell lines and screening by Flow Cytometry.
• Selection of commercial protein reagents and their validation
• Recording of data and inventory reagents using electronic laboratory notebook
• Production of certificates of protein analysis to external vendors (CROs) and collaborators
• Generation and presentation of data from PowerPoint slides at small and larger group meetings

Qualifications:

• B.S. or M.S. in biochemistry, or related discipline will be considered for Research Associate level with a minimum of 2 years of hands-on experience for Sr. Research Associate
• Experience in protein expression in bacterial and mammalian (HEK, CHO) systems, and purification using AKTA or similar FPLC systems is required
• Prior experience with, or desire to learn, characterization of antibodies and proteins using SDS-PAGE, analytical size-exclusion chromatography and Western-blotting
• Experience in antibody production and characterization, to include flow cytometry and affinity measurement, is strongly preferred but not required
• Proficiency with Microsoft Office programs is required. Proficiency using data analysis software (FlowJo, Prism, Excel) is preferred but not required
• Collaborative, growth-mindset, and well-organized approaches to work, as well as excellent verbal and written communication, and presentation skills are required

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD 

We are hiring for an experienced and highly motivated Principal/Associate Director level Scientist (dependent on experience)  to lead in vitro efforts to identify lead TRuC candidates for solid tumor targets. You will report to the Sr. Director of Immunology Research and you will guide and manage a collaborative cross-functional team in the design and implementation of studies to elucidate TRuC T cell functions, and to inform lead nomination and go/no-go decision on programs across early discovery, late discovery and pre-IND stages. You will have a profound understanding of T cell biology and the regulation of T cell functions by the tumor microenvironment, with proven track record in leading the efforts to understand the mechanism of action of engineered T cells and improve the function of T cells. If working on cutting edge T cell research sounds exciting, we’d like to hear from you!

Responsibilities:

• Lead and mentor a group of PhD and non-PhD level scientists in the development and implementation of in vitro assay cascades that effectively identify optimal lead TRuC T cell candidates against various tumor-associated antigens, including TRuC T cells targeting multiple antigens
• Apply a deep understanding of target biology and T cell immunology in the design of efficient screening strategies that interrogate TRuC T cell function and fitness/persistence
• Accurately interpret complex in vitro data sets utilizing a thorough theoretical and practical knowledge of binder and target structure/function relationships
• Continuously evaluate new technologies and assay formats for T cell functional characterization to increase the throughput, efficiency, and confidence in lead identification
• Collaborate closely with the binder discovery, vector development and in vivo pharmacology teams to coordinate resources, manage program timelines and ensure quality delivery
• Manage the preparation of data packages for lead nomination and for presentation to internal stakeholders and external parties; author and prepare manuscripts for publication

Requirements:

• Ph.D.* in immunology or similar discipline with 5+ years of post-Ph.D. research experience with 2+ years of experience developing CAR-T cells or similar engineered T cell platform, preferably in an industry setting.
• Experienced people manager and leader of cross-functional discovery teams
• Demonstrated ability to empirically guide lead optimization strategies through applied knowledge of binder/target structure-function relationships; experience with binder optimization and through various approaches
• Track record of success in leading functional binder screening efforts for engineered T cell therapies using various binder formats (scFv, sdAb or Fab)
• Deep knowledge of T cell biology with keen insight into the biology of T cell effector function, differentiation/polarization, exhaustion/persistence and stimulatory/inhibitory regulatory mechanisms
• High level of expertise in assays characterizing T cell phenotype and function, including but not limited to cytotoxicity, proliferation, cytokine production, chemotaxis, multiparameter immunophenotyping, and NGS analysis
• Strong working understanding of tumor cell biology and strategies to overcome mechanisms of immune evasion
• Must be a highly effective collaborator with strong written/verbal communication and interpersonal skills

*Candidates without a PhD may be considered if they have commensurate experience

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts and a  manufacturing facility in Rockville, MD which we can now call home for clinical & commercial manufacturing.

We are designing the state-of-the-art cell therapy facility in Rockville to utilize semi-automated and functionally closed systems which aim to provide cGMP manufacturing while optimizing the reliability of our cell therapy products and reducing manufacturing costs and vein-to-vein time. The flexible layout will allow production of gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline.

The Rockville, Maryland site will support clinical and commercial production of gavo-cel with a capacity to treat several thousand cancer patients annually. This site is expected to accelerate TCR2’s commercial-scale manufacturing timelines with production anticipated in 2023. We will be hiring for positions throughout manufacturing, supply chain, and technical operations, as well as other functions.

If you are interested in joining us on this exciting journey please submit you information for future consideration and tailored job alerts. 

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with clinical manufacturing facilities in Stevenage, UK and Rockville, MD. 

Passion is at the heart of our research.

Our mission as a leader in the solid tumor field will always be to bring meaningful cellular therapies to cancer patients. With our positive interim gavo-cel data, our 2021 strategic goals are aimed at developing our emerging pipeline and further advancing our clinical programs – meaning we’re looking for someone passionate and driven like you to help us bring our therapies closer to reality as we rapidly grow. Being a part of the TCR2 team means more than just research and execution. Our efforts stretch beyond the lab with how we engage with the community with TCR2 Cares, where we support the cancer community and STEM education.

We will be hiring across all functions. Please submit your information to join our talent community for future consideration.