Tessera Therapeutics is 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 / Director of Lipid Nanoparticles Process Development. This person will oversee a team of scientists and engineers, and be responsible for LNP synthesis process development with nucleotide cargoes and include, process scale-up, process execution to make material for pre/clinical studies, tech transfer to GMP facilities, and development of scale-down models, amongst others. This individual will lead a dynamic, rapidly growing, and highly collaborative team that is driving the LNP process development for a novel platform of Gene Writing.
- Build / lead the LNP production & process development team including research associates, scientists and engineers.
- Manage a core function of the team to produce, characterize, and optimize LNP production
- Establish a toolset to support LNP process development. This will include high throughput screening technologies and mixing systems for robust scale up to clinical production.
- Drive fundamental improvement of LNP synthesis understanding towards enhancements and simplification of LNP formation.
- Align LNP process development to support LNP formulation teams, with an emphasis on formulation definition, process robustness, scale-up, and stability.
- Lead the generation of preclinical LNP material generation.
- Lead tech transfer for clinical GMP production via internal and/or external contract manufacturing
- Drive the writing of protocols and technical reports to support 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
- MS with 12+ years or PhD with 8+ years of relevant industrial experience. Degree emphasis in Chemical Engineering, Biomedical Engineering, Bioengineering, is preferred
- In-depth track record of understanding and experience of RNA containing LNP synthesis and processing.
- Understanding of lipid chemistry, lipid modifications, lipid synthesis, and standard analytical techniques for macromolecules.
- Demonstrated understanding of the current therapeutic discovery, and process development, especially in gene therapy, gene editing, mRNA, RNAi, or antisense
- Technical understanding and experience in biopharmaceutical process manufacturing operations including industry cGMP environment and tech transfer to CMO/CRO.
- Experience with high-throughput process development techniques and statistical design of experiments (DoE) strongly preferred.
- Track record of completing deliverables within specified timelines.
- 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
- The successful candidate should be collaborative, communicative, and passionate about working with lipid nanoparticles leading to mediate the next generation of genetic medicines.
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.