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.
- 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!
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