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Executive Director, Upstream Process Development and Optimization
2 months ago
Sutro Biopharma, Inc. is seeking an experienced and visionary Executive Director to lead the Upstream Process Development and Optimization team. As a key member of the company's leadership team, you will be responsible for driving the development and implementation of cutting-edge upstream process technologies to support the company's pipeline of cancer therapeutics.
Key Responsibilities- Lead and direct the development and optimization of upstream processes, including fermentation, cell culture, and cell-free synthesis, to ensure efficient and scalable production of high-quality biologics.
- Develop and implement strategic plans to advance the company's upstream process development capabilities, including the development of new technologies and workflows.
- Collaborate with cross-functional teams, including Research and Development, Manufacturing, and Regulatory Affairs, to ensure seamless integration of upstream process development into the company's overall product development strategy.
- Develop and manage budgets to ensure effective resource allocation and meet company financial goals.
- Represent the company in regulatory engagements and author relevant sections of regulatory submissions, including DMF, IND, and BLA.
- Develop and implement quality control and quality assurance strategies to ensure compliance with regulatory requirements and company standards.
- Lead and motivate technical staff to achieve team goals and objectives.
- Develop and maintain relationships with external partners and vendors to ensure access to cutting-edge technologies and expertise.
- Bachelor's, Master's, or Ph.D. in Chemical Engineering, Life Sciences, or equivalent with at least 25 years of biopharmaceutical industry experience in microbial fermentation/cell culture process development and optimization.
- At least 3-5 years of practical experience in late-stage process development, including scaling up and transferring fermentation/cell culture processes to pilot and/or commercial scale.
- Experience with statistical design of experiments, advanced data analysis, and Quality by Design concepts.
- Extensive experience in regulatory engagements and BLA authoring is preferred.
- Detail-oriented with good organizational and collaborative skills and prior success working in a high-paced team environment to meet deadlines and prioritize work on multiple projects.
- Proven track record of excellent communication, both verbal and written, and the ability to build and maintain relationships with partners, customers, and collaborators.
Sutro Biopharma, Inc. is a clinical-stage company focused on the discovery and development of precisely designed cancer therapeutics. Our fit-for-purpose technology, including cell-free XpressCF, provides the opportunity for broader patient benefit and an improved patient experience. We have 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. We are headquartered in South San Francisco and are committed to creating a safe environment where our employees can grow and succeed together.
