Tessera Therapeutics is pioneering Gene Writing™—a new genome engineering technology that writes therapeutic messages into the genome to treat diseases at their source. Tessera Therapeutics was founded by Flagship Pioneering, an innovation enterprise that conceives, creates, resources, and grows first-in-category life sciences companies. Flagship Pioneering has created over 40 groundbreaking companies over the past fifteen years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Seres Therapeutics (NASDAQ:MCRB), Moderna (MRNA), Syros Pharmaceuticals (SYRS), Rubius Therapeutics (RUBY), Axcella Health (AXLA), Evelo Biosciences (EVLO), and Indigo Agriculture.
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, 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 process development 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
- 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.