Associate Director, Upstream Process Development (South San Francisco, CA)
Sutro Biopharma, Inc. is looking for An Associate Director of Upstream Process Development who will join the Cell-Free Group in developing processes using Sutro’s novel cell-free protein synthesis process (XpressCF®) to manufacture protein biotherapeutics. The individual will participate in cross-functional teams and collaborate on multiple projects to support development of product candidates in various stages from lead optimization, GMP manufacturing, as well as late-stage development toward commercialization. Responsibilities include working with multiple groups in R&D to improve product titers and product quality by examining the biochemical and physical factors affecting cell-free performance and scale-up. This role will also be involved in process transfers to internal and/or external manufacturing facilities, providing technical support during GMP productions (PIP, change control, deviations, CAPA, etc.), and supporting regulatory filings. Further duties may include development and qualification of scale-down models and conducting process characterization/process validation studies for late-stage programs. This position will also collaborate with the Platform Technology R&D group to further performance and understanding of Sutro’s underlying XpressCF® technology.
The successful candidate will work with the Upstream PD Pipeline team to design and execute cell-free protein synthesis experiments and develop new methods/techniques as needed. Work will focus on late-stage development (Phase 2 and later) of existing programs and also assist with early stage (pre-GMP and FIH production) for new programs. This position will interface with manufacturing sites (internal and/or external) to transfer new/improved processes and ensure consistent process performance. In addition, the successful candidate will be required to make presentations to internal teams and senior management and to author internal and external publications including contributions to regulatory submissions as needed.
We are seeking a highly motivated team-player with excellent problem-solving skills and experience with bioprocesses and microbial metabolism. Versatility is a must, as tasks will involve a range of reactors and scales and process modes. Good organizational skills and the ability to manage tasks within a timeline are essential.
The ideal candidate will have the following background/skill set:
- PhD with 7 or more years or BS/MS with 12 or more years of industry experience in Chemical Engineering, Bioengineering, Biochemistry, or a related discipline
Experience with the following is required:
- laboratory scale process equipment, especially bioreactors for microbial and/or mammalian culture
- bioprocess development for therapeutics (cell-free, microbial, and/or mammalian cell-based)
- process transfer to GMP manufacturing or support of existing GMP processes
Experience with the following is preferred:
- late-stage upstream process development (Process Characterization/Process Validation)
- scale-up to > 1000L bioreactor scale
- scale-down model development and qualification
- authoring regulatory documents (IND/BLA sections, responses to agency questions, etc.)
- Design of Experiments, statistical analysis, MVA
- cell-free protein synthesis
- metabolite/biochemical assays (HPLC and/or microtiter plate based)
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.
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.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
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.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development, and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines, and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.S