Tessera Therapeutics is an early-stage life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
This “boots-on-the-ground” scientific leader will be responsible for developing early-stage ex vivo cell based processes utilizing Tessera’s proprietary Gene Writing technology. We are searching for a driven, enthusiastic and self-motivated individual who is comfortable multitasking and working independently on various aspects of the platform. This individual will join a dynamic, rapidly growing, and highly collaborative team.
- The successful candidate will work both independently and as part of a collaborative team to lead small scale model development for gene-edited cell processing and manufacturing.
- Serve as a leader in the cell therapy process development lab and contribute to building out Tessera’s ex vivo manufacturing platform and team.
- Develop scale down models of immune cell processing including but not limited to isolation, selection, enrichment, gene delivery, expansion, and DS formulation.
- Lead the design and execution of process development studies that define critical performance parameters of Tessera’s Gene Writing technology as applied to ex vivo cell therapy.
- Perform in vitro cellular assays that investigates the impact of various Gene Writers on the phenotypic and functional capacity on primary cells.
- Support the development of standard operating procedures, batch records, and analytical sampling plans.
- Support internal and external process transfers to CDMOs and CROs.
- Present process data and research to Research and CMC program teams.
- Serve as a Subject Matter Expert (SME) for Tcell process development and manufacturing.
- Mentor and train research associates.
- M.S. (with 4-6 years of cell therapy industry experience) or Ph.D. (with 2-4 years of cell therapy industry experience) in Immunology or related field is required.
- Experience developing scale down models as well as with large scale closed systems for immune or other primary cell based process development and manufacturing.
- Experience with chimeric antigen receptor (CAR) based therapy and knowledge of T-, NK-, B- or stem cell product attributes, including an understanding of analytical methods for characterization (flow cytometery, ELISA, qPCR, etc…)
- Experience with viral and non-viral mediated gene delivery for ex vivo manufacturing processes.
- Working knowledge of design of experiments (DoE) and statistical analysis
- Excellent technical, written, and oral communication skills
- Has a passion for collaboration and a mindset for cross-functional performance in a thriving early-stage biotech environment.
- Experience in supervising, mentoring, or managing research associates.
- Experience with cGMP requirements and transferring processes to cGMP manufacturing.
- Knowledge and experience with non-viral gene delivery and gene editing a plus.
- Experience applying Quality by Design (QbD) concepts with an eye towards process robustness.
- Familiarity with FDA and EMA guidance for cell and gene therapy.
More About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $50B in aggregate value. To date, Flagship has deployed over $2.2B in capital toward the founding and growth of its pioneering companies alongside more than $18B of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Sigilon Therapeutics (NASDAQ: SGTX).
Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.