Sutro Biopharma is seeking a Director to lead our assay development group 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.
The candidate will lead assay development activities, including method qualifications and transfers, required for IND-stage molecules. This position will lead interactions with cross-functional areas such as research, upstream and downstream process development groups, quality control and quality assurance. This position will 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, including managers.
- PhD in analytical chemistry, biochemistry, molecular biology or related scientific field and 10+ 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 Analytical Development, as well as a knowledge of cGMPs, ICH, and relevant FDA guidelines and experience in writing relevant regulatory submissions. Experience in IND-enabling stability study design and management is preferred.
- Demonstrated proficiency in both hands-on analytical work, the ability to manage activities and solve analytical challenges at third party pharmaceutical manufacturers, and extensive experience reviewing and organizing analytical data.
- Demonstrated ability to work independently across functional areas to design novel activity assays that can be implemented in a quality control lab.
- 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, and stock options.