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 downstream process development (pre-IND to commercial), including protein purification and conjugation. Lead, motivate, and develop technical staff.
- Write and review relevant CMC sections of regulatory submissions (IND, INDa, BLA)
- Transfer downstream processes to Sutro manufacturing site and/or partner sites
- Set long-range strategies for technology development, including IP management to ensure FTO
- Represent Downstream 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 protein purification (including multiple modes of chromatography, depth and membrane filtration, and ultrafiltration/TFF). Extensive knowledge of product variant and process-related impurity removal strategies.
- Extensive experience in scaling up purification processes to pilot and/or commercial scale
- Experience with statistical design of experiments, advanced data analysis, process validation, and Quality by Design concepts is expected
- Experience with protein conjugation process chemistry and protein formulation is helpful, but not required
- Significant experience in authoring regulatory submissions (IND, INDa, BLA, etc.)
- At least 10 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, and stock options.