Tessera Therapeutics is an early-stage life sciences company pioneering Gene Writing™, a new biotechnology designed to offer scientists and doctors the ability to write and rewrite 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-class category companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $34 billion in aggregate value. To date, Flagship is backed by more than $4.4 billion of aggregate capital commitments, of which over $1.9 billion has been deployed toward the founding and growth of its pioneering companies alongside more than $10 billion 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, Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Syros Pharmaceuticals (NASDAQ: SYRS).
Tessera Therapeutics is seeking a Director of mRNA Manufacturing and Formulation. This person will oversee a team of scientists and engineers, and be responsible for mRNA synthesis process development, mRNA formulation process development, process scale-up, process execution to make material for preclinical studies, tech transfer to GMP facilities, and development of scale-down models, amongst others. They will bring deep molecular biology, biochemical engineering, and process development expertise.
- Lead the mRNA manufacturing and formulation teams
- Contribute to the development of in-house mRNA production capabilities, with an emphasis on establishing a scalable/transferable process for producing high-purity material.
- Review experimental plans for screening, optimization, and scale-up efforts for mRNA production, chromatographic separations and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
- Develop and qualify reliable scale down models for high-throughput screening experiments
- Manage a core function within the team to supply high quality mRNA for platform and pipeline experiments, and participate/present to cross-functional teams.
- Contribute to development of an LNP formulation process, with an emphasis on formulation definition, process robustness, scale-up, and stability.
- Screen lipids to identify compatibility with Gene Writer technology and drug targets in collaboration with the platform team
- Lead selection, tech transfer, and coordination of contract manufacturing organizations (CMOs) for GxP material supply
- Define technical requirements of the process unit operations for implementation at CMO, including equipment specification/selection, draft procedures and recommended operating parameters/ranges, and raw materials definition and preparation.
- Write protocols and technical reports to support drug substance and drug product clinical development.
- Organize workstreams and complete individual 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 scientist
- Responsible for mentoring a team of scientists in the laboratory and supporting the design, execution and interpretation of experimental studies
- MS with 12+ years or PhD with 8+ years of relevant industrial experience. Degree emphasis in Biochemistry, Chemical Engineering, Molecular Biology, Bioengineering, Genetics or related field is preferred
- Technical understanding and experience in biopharmaceutical process manufacturing operations in an industrial cGMP environment
- Understanding of nucleic acid chemistry, enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for macromolecules.
- In-depth understanding of DSP operations of biologics such as chromatography and ultrafiltration is required. A proven track record of purifying multiple drug modalities is strongly preferred.
- Hands on experience with in vitro transcription and mRNA purification technologies is a plus
- Experience with Technology Transfer of manufacturing processes
- Experience with high-throughput process development techniques and statistical design of experiments (DoE) strongly preferred.
- Understanding of requirements for development of biologics including requirements for product comparability.
- Experience in working with vendors.
- Track record of completing deliverables within specified timelines.
- Knowledge of GMP/ICH/FDA regulations strongly preferred.
- Demonstrated understanding of the current therapeutic discovery and development process, especially in gene therapy, gene editing, mRNA, RNAi, or antisense
- A strong self-starter, independent thinker, with a strong attention to detail
- Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner
- The ability to effectively influence the work of others
- Eager to work with highly skilled and dynamic teams in a fast-paced, entrepreneurial and technical setting
- Experience managing multiple bench researchers
RECRUITING & 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.