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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, ovarian cancer, NSCLC, and cholangiocarcinoma. 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.

As the Associate Director, Data Management (AD, DM) and first hire in the Clinical Data Management (CDM) group. Reporting to the VP, Clinical Development Operations you will ensure the quality for all Data Management (DM) deliverables. You will be looked to as the Data Management SME and responsible for setting the group strategy, standards, and growth plans as the team progresses into later stage development. 

Responsibilities:

• Strategic build out of the Data Management sub-function within Clinical Development
• Develop and implement data management standard working practices for regulatory inspections and or submissions
• Oversee the planning and management of external Data Management, and associated vendors across all clinical trials
• Responsible for  data transfer specifications, imports, and data integrity processes
• Ensure achievement of major Data Management deliverables in collaboration with other TCR2 departments including Clinical Operations, Clinical Safety and Pharmacovigilance, Translational Sciences, and Statistics
• Represent Data Management function on the Clinical Sub-team ensuring aligned expectations between the CRO and TCR2 for all data related deliverables, especially to support essential decisions and regulatory submissions
• Represent function in external professional projects and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of TCR2
• Provide input to functional governance with TCR2 strategic suppliers and vendor partners
• Participate in review of budgets/invoices relating to Data Management activities

Requirements:

• BS degree in analytical or health-related field
• 8+ years data management experience in the pharmaceutical industry. Prior management experience preferred 
• Experience managing vendor relationships and alliance partnerships
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Experience with budget planning
• Prior experiences with inspection readiness, regulatory submission and strong CRO oversight.
• Excellent organizational skills, highly collaborative & supportive, attention to detail, communication, time management, and flexible attitude with respect to work assignment
• Proficient in multiple EDC platforms, related processes, and data visualization/graph tools (i.e.: Power BI, Tableau, SAS VA, GraphPad, etc.)
• Working knowledge of SAS, SQL, database design and database concepts
• Strong knowledge of CDISC standards (CDASH/SDTM)
• Understanding of coding (MedDRA, WHO drug dictionaries)
• Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Self-starter and must function well under minimal supervision

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 at in Cambridge, MA.

We are seeking an Accounting Manager/Sr. Manager (CPA), dependent on experience, to join our Finance team. Reporting to the VP, Corporate Controller, you will be someone who is highly organized and has a strong understanding of accounting, contract accruals, month-end close process, financial statement presentation, and excellent Excel skills. This position requires strong oral and written skills as well as effective interpersonal skills. It also requires the ability to meet frequent deadlines and to perform responsibilities within tight schedules. This is an opportunity to join a growing Biotech company and get experience with associated accounting practices.

Responsibilities:

• As a key team member, you will be responsible for supporting the Company’s close process including performing CRO/CMO/contract accruals, account reconciliations, and variance analyses while ensuring policies and procedures are followed to comply with the requirements of Sarbanes Oxley
• Collaborate with Research and Clinical Development operational teams to review and understand study/program plans, clinical trial accruals, and related third-party contracts.
• Establish and maintain strong business partnerships with key counterparts including Research, Clinical, FP&A, and accounts payable
• Perform continuous assessment of the close process and process re-engineering to help reduce the month-end close timeline
• Assist with financial statements on a monthly basis
• Assist with development and implementation of internal control policies and procedures.
• Collaborate with accounts payable to review purchase orders, ensure accurate coding of expenses, and monitor payments to vendors
• Assist in the coordination of annual audit and quarterly review activities of external auditors.
• Other duties as assigned

Requirements:

• Bachelor Degree in Accountancy or Business required
• Minimum 5+ years combined in public or private accounting
• Strong knowledge of US GAAP, internal controls, quarter-end close and reporting process
• Experience at a Public Company and CPA required. Public accounting experience is preferred
• Excellent written and verbal communication skills
• Sound problem-solving abilities
• An ability to be productive and successful and work under tight deadlines
• Exceptional attention to detail
• Strong interpersonal skills and a positive work ethic
• Flexible to changing priorities
• Advanced Excel skills required and proficiency with other Microsoft Office products
• NetSuite experience preferred

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 and TC-510 for solid tumors. 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 have a clinical manufacturing facility located in Rockville, MD. This role is located at 10 Wilson Rd in Cambridge. 

The TCR2 team is expanding, and we are hiring a Manager/Sr Manager to join our team to help coordinate and manage later stage lentiviral vector characterization and manufacturing efforts to support our growing pipeline. You will report to the department head and work closely with cross-functional teams including analytical development, manufacturing, quality, and regulatory departments during execution as required.

This 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: 

• Lead coordination, documentation, and execution of end-to-end drug substance process characterization activities.
• Complete drafting and review of documentation to support eventual drug substance process qualification activities.
• Utilize project management and communication skills to help coordinate project plans and ensure successful execution of activities.
• Provide support to manufacturing investigations and regulatory filings as required within ongoing manufacturing activities.
• Provide updates on project status and deliverables to CMC and cross-functional teams as required.

Requirements: 

• BS or MS in chemical engineering, biochemical engineering, or related discipline and at least 5 years of industry experience.
• Technical experience with vector development and/or biologics manufacturing is required.
• Solid foundational knowledge of GMP manufacturing principles and experience working with external CMO/CTOs is preferred.
• Knowledge of process validation principles, including process characterization design and execution through performance qualification preferred.
• Familiarity with authoring documentation to support quality investigations as well as regulatory submissions 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 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 role is based in Cambridge, Massachusetts.

We are looking for a Quality Control Associate to work 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 Manager of External Quality Control and collaborate closely with our 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 work on 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, 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:

• Review and evaluate test data, COA/COCs, and other test information to support the release of drug product for clinical use
• Monitor, analyze, trend, review and report test results.
• Support investigation and resolution of issues causing out-of-specification or out-of-trend results
• Participate in improvements to analytical testing strategy.
• Take an active role in the oversight and continuous improvement of partner company QC operations, particularly analytical testing

Requirements:

• Bachelors or Masters degree in Biochemistry, Micro/Molecular Biology, or related field.
• Minimum of 2 years experience in QC or Analytical Development role in a biotech or biologics operation
• Proficiency in GDP, and experience in analytical method data review and verification.
• 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 preferred.
• Technical writing skills, specifically with effective protocol.
• Excellent communication and collaboration skills required.
• Possess a flexible yet pragmatic approach to problem solving.
• 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. This role will be based in Cambridge, MA.

We are looking for an enthusiastic, motivated Associate Director, Clinical Quality to provide oversight to the GCP systems and compliance of our clinical studies. You will report to our Director, Quality Assurance, and work closely with groups throughout the organization to ensure compliance with regulatory requirements and to support clinical initiatives. The individual in this role will be responsible for providing Quality support to the external and internal functions to ensure robust processes and systems are implemented to support the clinical programs. 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, come grow your career with us.

Responsibilities:

• Lead the GCP quality program including implementation of the GCP Quality Management System.  This will include ownership and/or oversight of procedures, records, and business processes
• Form and leverage collaborative partnerships with key cross-functional stakeholders such as Clinical Leads, Regulatory Affairs, Research and Development, Manufacturing, and other relevant stakeholders.
• Develop and own the Clinical Vendor Quality Management program. This is expected to include risk-based strategy planning, compliance monitoring, and leading and performing audits of clinical sites, vendor, internal systems as well as clinical, data collection and processing activities.
• Lead/support inspection readiness and inspection preparation activities, including post-inspection and response generation.
• Identify, Develop, and Report GCP metrics for Management Review and own continuous improvement actions.
• Drive continuous improvement and knowledge management by monitoring and mitigating risks
• Represent Quality in clinical study teams and external parties including CROs, vendors, and investigator sites and promote a high level of quality and consistency across and within programs
• Provide review, content editing, and/or approval of clinical and R&D documents including regulatory submissions, study reports, protocols, and SOPs.
• Be accountable for defining and driving systemic/programmatic clinical data integrity by working collaboratively with CRO, site, and internal functional teams in compliance with regulations and study protocol and procedures.
• Provide expertise and guidance on GCP and applicable regulations to clinical teams to proactively identify compliance issues/risks and recommend/implement mitigations.

Requirements:

• Bachelor’s degree in the biological sciences or related field, Master’s degree preferred.
• 10+ years of experience combining clinical monitoring and GCP-based quality assurance experience in the pharmaceutical/biotechnology field.
• Experience influencing decisions and actions at third party/remote sites in Sponsor role
• Track record of successful application of GCP regulations and guidelines published by and interaction (written and verbal) with FDA and other health authorities.
• Process-oriented, with the ability to demonstrate good judgment and decision-making.
• Exceptional organizational skills and ability to deal with competing priorities.
• Budget and contract staff management experience.
• Experience with Protocol, ICF, CRF, CSR development and review.
• Strong technical writing skills, specifically with effective report, investigation documents experience.
• Excellent communication, collaboration, partnering, and influencing skills required, specifically demonstrated in working with remote/off-site third-party partners.

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. The Quality Assurance Sr. Associate will support quality operations under 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 QA Sr. Associate will support Research Operating Procedure development, document control and 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, assit with external audits.
• Conduct training for GMP and GDP processing.
• Perform deviation review and implementation of CAPA to improve product quality.

Qualifications and Experience:

• Bachelor’s degree in the biological sciences or related field.
• Minimum of 3 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 clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA.  We are looking to expand our quality organization with a Quality Assurance Documentation and Training Specialist to join the TCR2 Quality Systems and Engineering team.  In this job you will maintain and execute documents, conduct archival and storage, issue training and maintain employee training files. In addition, the individual may participate in more complex projects, operational excellence initiatives, and quality systems with supervision.

Responsibilities:

• Perform routing, review, and approval activities in Part 11 compliant electronic system
• Perform a thorough review of all SOPs, ROPs, Policies, protocols, reports and records for formatting and consistency
• Interact with and support subject matter experts, area managers/supervisors, and others in the organization for document control needs.
• Maintain the electronic and physical archival of records and assure documents are readily available to authorized personnel
• Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods
• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for all projects.
• Managing ongoing operations of Training plans
• Issue and maintain training of new and incumbent personnel
• Track training progress and ensure timely completion of assigned training
• Assist in the development and/or review developed training
• Help to review and updates existing training materials as required.
• Performs other duties and tasks as required

Requirements:

• Bachelor’s degree required or 2-4 relevant work experience in a GMP regulated industry
• Excellent interpersonal and communication skills to work well in a team environment
• Forward thinking with a proactive approach; thinking outside the box for creative solutions
• Detail-oriented with the ability to multitask to handle multiple projects
• Proven time management and organizational skills
• Ability to work in a fast-paced environment with multiple priorities
• Ability and desire to learn new skills and computer systems
• Proficient with Microsoft Suite (Word, Excel, PowerPoint)
• Must be authorized to work in the U.S.

Preferred Experience

• Experience with Veeva is highly desired
• Experience with an EDMS
• Experience with an LMS

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 a Sr. Quality Associate to lead a phase-appropriate supplier qualification and management program. As a member of the TCR2 Quality Systems and Engineering team, you will report to our Quality Systems Manager and work closely with Quality Assurance, Process Development, Supply Chain, and our external partners. Your responsibilities in this role have a direct impact on the quality, safety, and efficacy of the cell therapies provided to patients. This is a great opportunity for someone looking to expand their quality experience and skills into Supplier Quality Management. Come grow your career with us!

Responsibilities

• Supports the development and maintenance of GxP phase-appropriate strategies for the qualification and performance monitoring of suppliers to ensure compliance with applicable regulations and TCR2 procedures
• Manages the assignment and assists with the performance of supplier audits (remote and onsite) on a regular basis to ensure suppliers and their supplies remain in compliance
• Facilitates the generation and maintenance of quality agreements, questionnaires, and certifications with third parties
• Coordinates the handling of supplier change notifications, including the performance of internal impact assessments
• Leads supplier performance reviews; tracks and trends supplier performance via supplier scorecards, taking remedial action as needed
• Manages the handling of supplier corrective action requests (SCARs)
• Participates in the development of raw material qualification and inspection requirements
• Manages and carries out the internal audit program
• Creates, maintains, and distributes quality metrics to upper management on a routine basis, includes identifying, reporting, and escalating relevant quality issues
• Manages moderate complexity projects with minimal direction
• Authors / writes and reviews SOPs / documentation
• Mentors and trains junior team members
• Trains new hires, as applicable
• Other duties, as assigned

Requirements

• Bachelor’s degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering.
• 4-5 years of related experience in GMP or Medical Device regulated industries
• Previous experience with the following quality processes is required: Change management, CAPAs, Deviations, Risk Management, Root Cause Analysis
• Understand and interpret regulations and standards (i.e, 21 CFR part 11, 210/211, 606, 820, ISO 9001, 13485, 17025, 19011, and EU industry standards)
• Proficient with Microsoft Suite (Word, Excel. PowerPoint), experience with Visio is a plus.
• Experience working with Veeva is preferred
• Ability to communicate clearly and effectively with all levels of the organization.
• Excellent verbal and written communication skills
• High level analytical and critical thinking skills
• Must be authorized to work in the U.S.
• Travel up to 15%