CMC Project Manager
TCR² Therapeutics Inc. is a clinical stage immunotherapy company developing novel T cell therapies for patients suffering from cancer. TCR² has developed a unique proprietary TRuC™ platform which can reprogram the natural TCR complex to recognize specific antigens found on tumors where they elicit rapid killing of cancer cells. The company has demonstrated activity against both hematological and solid tumor targets in preclinical models and believes its TRuC™-reprogrammed T cells will serve as the engine for important therapies. TCR² is a publicly traded company and has scientific and clinical operations in Cambridge, MA.
TCR² Therapeutics is seeking a strong and skilled CMC project manager to drive process development and CMC activities to support early stage clinical development programs. The Project Manager will be a liaison between Process Development, Manufacturing and Program Management groups. CMC Project Manager will partner with internal team leaders and external partners to develop, track, and implement various process development and CMC projects to support TCR² Therapeutics’ development programs. The ideal candidate will identify, implement, and organize CMC activities and support Program Management group to successfully execute projects, clinical development strategies and portfolio scenario-building and planning.
Partner with Process Development and Manufacturing groups to manage CMC activities for multiple complex early stage development projects.
Develop and maintain integrated CMC project plans (internal program trackers, dashboards and databases) to identify/communicate inter-dependencies as well as critical path activities across multiple programs.
Work collaboratively with CMC functions (Process & Analytical Development, CMO & CDMO partners, Quality Control, Quality Assurance, and Regulatory) to track milestones and coordination of program deliverables for successful management of projects.
Partner with Project Teams to implement best practices across project teams e.g., resource capacity planning, project risk management, team performance, timeline development, portfolio management.
Track and monitor key milestones and decision points to drive delivery of project objectives.
Identify and help manage risks, conflicts and barriers to project success.
Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various CMC projects, as well as ensure CMC teams are aware of current integrated program timelines.
Facilitate CMC and project team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of objectives.
Incorporate financial and resource allocation aspects into project plans.
Assist Program Management Lead in assuring a high-performance team spirit and high functioning team.
Directly manage projects with minimal supervision.
Bachelors Degree in life science or a health-related with a minimum of at least 5 years Biotech/Pharma and 3 years in Project Management or equivalent required.
Advanced degree (MS or MBA) and PMP certification desired but not required.
Skills and Abilities:
Prior experience in development of biologics is preferred and experience with gene or cell therapy discovery and development is a plus.
Broad knowledge of the clinical development and biopharmaceutical manufacturing process.
Strong analytical, problem-solving, and critical thinking skills.
Must be able to interact and communicate effectively at all levels of the organization.
Must be competent in utilizing information technology systems and project management tools including systems (MS project, One Pager, Microsoft Visio, Excel and others).
Excellent organizational and time management skills.
The ability to independently lead several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving.
Thrives in a fast-paced and evolving environment.
Travel is not frequently required (<5%).
Interested candidates should send their resume to firstname.lastname@example.org