Director, Upstream Process Development
Sutro Biopharma, located in South San Francisco, has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best-in-class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches. These therapeutics will significantly extend the clinical impact of current oncology/autoimmune therapeutic approaches and are beyond what can be envisioned with traditional cell-based expression technologies. Sutro’s biochemical synthesis technology, which underpins these therapeutics, allows the rapid and systematic exploration of many protein drug variants to research, discover, and develop drug candidates. Our make-test cycle for hundreds of protein variants, including those incorporating non-natural amino acids, takes approximately two weeks. Once identified, production of these protein drug candidates can be rapidly and predictably manufactured at commercial scales. In addition to developing its own drug pipeline, Sutro Biopharma is collaborating with select pharmaceutical and biotech companies in the research, discovery, development, and manufacture of novel protein therapeutics.
Sutro Biopharma, Inc. is looking for a technical leader who will report to the Vice President of Process and Analytical Development. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment.
- Responsible for leading and directing all aspects of upstream process development (pre-IND to commercial), including fermentation, cell-free synthesis, and microbial extract spray drying processes. Lead, motivate, and develop technical staff.
- Write and/or review relevant CMC sections of regulatory submissions (DMF, IND, BLA)
- Transfer upstream processes to Sutro manufacturing site and/or partner sites
- Set long-range strategies for technology development, including IP management to ensure FTO
- Represent Upstream Process Development on cross-functional teams
- Produce significant documents or publications (internal/external) supporting company policies and goals
- Present to senior management and at conferences; exert influence inside and outside Sutro through publications and meeting participation
- B.S., M.S., or Ph.D. in chemical engineering, life sciences, or equivalent with at least 15 years (B.S., M.S.) or 10 years (Ph.D.) of biopharmaceutical industry experience in microbial fermentation/cell culture process development and optimization. Knowledge of upstream process effects on product quality expected.
- Extensive experience in scaling up and transferring fermentation/cell culture processes to pilot and/or commercial scale, including multi-site/CMO interactions and demonstrated business acumen
- Experience with statistical design of experiments, advanced data analysis, process validation, and Quality by Design concepts is expected
- Experience with cell line development is helpful, but not required
- Significant experience in authoring regulatory submissions (IND, BLA, etc.)
- At least 5 years of experience supervising technical staff, including managing managers
- Proven track record of excellent communication, both verbal and written, and the ability to build and maintain relationships with partners, customers, and collaborators
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.