Director, Upstream Process Development
- Employer
- Sutro Biopharma, Inc
- Location
- South San Francisco, CA, United States
- Start date
- Jan 11, 2021
View more
- Discipline
- Engineering, Process Engineer, Manufacturing & Production, Process
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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.
Responsibilities
- 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
Qualifications
- 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
Please submit resume for Req. #2067 to jobs@sutrobio.com . Please visit our website at www.sutrobio.com for more information.
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.
Company
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.
Stock Symbol: STRO
- Website
- http://www.sutrobio.com/
- Phone
- 650.881.6500
- Location
-
111 Oyster Point Blvd
South San Francisco
California
94080
United States
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