We are seeking an Associate Director to join our Analytical Development group to support CMC activities for monoclonal antibodies and antibody drug conjugates.
The candidate will work closely with the CMC groups to contribute substantially to the successful analytical development activities required for IND stage molecules. 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.
• PhD in analytical chemistry, biochemistry, molecular biology or related scientific field and 8+ years of industry experience in the characterization of monoclonal antibodies/antibody drug conjugates is required OR
• MS in analytical chemistry, biochemistry, molecular biology or related scientific field and 15+ years of industry experience in the characterization of monoclonal antibodies/antibody drug conjugates is required.
• Requires a strong background in Analytical Development, stability study design and management, as well as a thorough knowledge of cGMPs, ICH and relevant FDA guidelines and experience in writing relevant submissions.
• 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.
• 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.
Please submit resume for Req. #1704 to email@example.com. Please visit our website at www.sutrobio.com for more information. SF Bay Area, no relocation.