Associate Director, Analytical & Formulation Development
Sutro 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.
Sutro Biopharma is seeking an Associate Director to join out Analytical Development group to lead the activity/impurity assay development team which supports Sutro’s clinical candidate pipeline of antibodies, antibody drug conjugates, and additional novel protein/conjugate therapeutics with primary focus on early-stage programs.
- Lead activity assay development activities, including method qualifications and transfers, required for IND-stage molecules.
- Responsible for plate-based process impurity assays and Sutro proprietary raw materials assay support.
- Lead interactions with cross-functional areas such as research, upstream and downstream process development groups, quality control and quality assurance.
- Provide input and data for regulatory filings.
- Actively participate in the design of specifications in alignment with control strategies in a changing developmental environment for drug substance and drug product.
- Actively communicate and collaborate with colleagues and third-party vendors to ensure optimal execution and record of analytical activities.
- This position will have direct reports.
- PhD in analytical chemistry, biochemistry, molecular biology or related scientific field and 8+ years of industry experience in the characterization of large molecule biologics is required OR
- MS in analytical chemistry, biochemistry, molecular biology or related scientific field and 15+ years of industry experience in the characterization of large molecule biologics is required.
- Requires a strong background in Potency Assays/Plate Based Impurity Assays, as well as a knowledge of cGMPs, ICH, relevant FDA guidelines and experience in writing relevant regulatory submissions. Experience in IND-enabling stability study design and management is preferred. Demonstrated use of automation for activity assays is desired.
- Demonstrated proficiency in both hands-on analytical work, the ability to manage activities, solve analytical challenges at third party pharmaceutical manufacturers, extensive experience reviewing and organizing analytical data.
- Thorough understanding of ELISA and cell-based assays combined with the experience in developing assays is essential, qualifying and transferring assays to QC environment is desired.
- Knowledge of additional analytical assays such as chromatography, icIEF and capillary electrophoresis is desirable.
- Demonstrated leadership ability, including a commitment to mentorship and development of personnel.
- Flexibility to work on multiple projects in a fast-paced environment is essential.
- Good communication skills are essential.
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.