LOCATION: Waltham, MA
TScan Therapeutics is a startup biotechnology company that seeks to revolutionize life-changing therapeutics for patients by identifying and manufacturing novel engineered T cell products. We are looking for an experienced cell and gene therapy product manufacturing specialist to lead our CMC/Technical Operations team. This new position will be a senior member of the Technical Development & Manufacturing Team and will report to the Vice President of TDM. Key activities will include the development and execution of strategic manufacturing plans involving internal and external relationships with CDMO and CMO partners to ensure stable and phase-appropriate supply chains.
The ideal candidate will (i) have a strong background in manufacturing cell and gene therapy products; (ii) have a firm understanding of the cGMPs and ICH guidelines related to the manufacture of human cell therapies; (iii) be an effective problem solver who is energized by a fast-paced, lean and agile environment; and (iv) be a team player who can establish and maintain effective and productive relationships with internal colleagues and with multiple external partners.
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious diseases. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
- Help develop and execute on strategic manufacturing plans for viral and/or non-viral vectors and engineered cell products. Specifically, the selected candidate will have responsibility for the RFP process, vendor and site auditing, multiple CMO contract negotiations, including Master Service Agreements and Quality Agreements
- Act as CMC/TechOps SME for all internal and external discussions as strategic plans, timelines and operating budgets for vector and cell product manufacturing campaigns are developed, executed and reported
- Generate vector and cell product Risk Assessments to support manufacturing decisions, activities and regulatory filings
- Establish and manage cold chain logistics for clinical supply as well as chain of identity/chain of custody tracking of patient- and donor-derived materials.
- Author and review technical documentation and regulatory filings to support all early stage clinical manufacturing activities
- Responsible for implementing methods to establish TScan Quality System Management policies and mechanisms to ensure full compliance
- BS or PhD degree with at least 10-15 years of relevant industry experience in CMC/TechOps specific activities. Experience with successfully establishing new clinical supply capabilities for cell and gene therapy products is essential
- Scientific creativity, critical thinking, ability to innovate, and analytical problem solving
- Excellent communication skills (both written and oral)
- Experience and proven success drafting manufacturing scenarios for long range planning
- Thorough familiarity with regulatory authority policies and guidelines pertaining to vectors and cell therapy products that are essential for successful drafting and submission of CMC sections of INDs and CTDs
Do YOU have the anatomy of a TScanner?
Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our new offices in Waltham, MA have over 10,000 square feet of premium lab and office space, as well as 4000 square feet of GMP manufacturing suites which provide an environment to support innovation, camaraderie, professionalism and success. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.
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Head of CMC/Tech Operations