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.
Tessera Therapeutics is seeking an Associate Director of Analytical QC to lead a team to execute the QC release of critical raw materials and reagents to support a range of modalities including DNA, RNA, LNP & AAV. The initial focus is to support R&D and preclinical support which will progress to include GMP release and stability testing execution. The position will work with Analytical Development to transfer, qualify and validate (as needed) assays for preclinical and clinical release and stability. The candidate will bring deep analytical expertise to all aspects of release / stability testing, specifications setting, analytical investigation and CMC analytical strategy. This individual will join a dynamic, rapidly growing, and highly collaborative team that is driving multiple modalities for a novel platform of Gene Writing.
- Lead the Analytical QC testing execution strategy for critical raw material and reagent release to support all aspects of R&D including platform, therapeutic development, and process development teams.
- Guide and write analytical technical reports, release / stability protocols and specifications
- Enable analytical specification settings for raw material and reagents.
- Direct the analytical investigations for out of trend and out of specifications
- Collaboratively support the CMC strategy, interactions with QA and Regulatory , across preclinical / clinical development and GMP activities
- Manage and coordinate external contract QC testing via CRO/CMO activities.
- Organize workstreams and team objectives to maintain project timelines.
- Manage interactions across the company on behalf of the team to ensure alignment of the team’s activity with company priorities
- Build and lead a team of research associates and scientists
- MS with 12+ years or PhD with 8+ years of relevant industrial experience. Degree emphasis in Analytical Chemsity, Chemistry, Biochemistry, Bio / Chemical Engineering, Molecular Biology, , Genetics or related field is preferred
- Track record of Analytical QC release testing of raw materials and reagents to support preclinical / clinical development of biological candidates in the areas of AAV, DNA/RNA &/or LNP.
- Experience of managing / executing high throughput QC testing workflows
- Technical understanding and experience of CMC strategy execution for Analytical QC, QA, and Regulatory to support preclinical / clinical development to cGMP production.
- Track record of collaborative expertise in executing protocols from analytical method development teams.
- Experience of managing and executing analytical investigations (out of trend, out of specification)
- Led external testing strategies with contract testing labs, CRO’s and CMO’s
- Experience of leading a dynamic and highly skilled team in a fast-paced, entrepreneurial and technical setting
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).