We are partnered with a small biotech based in East Bay that is focused on developing therapeutics for discovery through development of chronic immune diseases. They are seeking a talented Associate Director of Drug Substance Development to leading on preclinical and clinical stage API process development from lab scale to large scale with CROs/CDMOs. This is an ideal opportunity for someone who is seeking a small biotech environment.

Responsibilities:

• Lead on API process research and development chemistry, developing phase appropriate routes for manufacturing of small molecules and peptides
• Analyze data and compare solid and liquid phase peptide synthesis, communicating results with internal and external stakeholders
• Develop and execute manufacturing strategy of drug substance, starting materials, raw materials - managing/selecting a global network of CDMOs
• Contribute to relevant sections of regulatory filings

Requirements:

• PhD in organic chemistry or a relevant discipline and 7+ years of industry experience in leading drug substance development for peptides or small molecules. An MS or BS with significant and relevant industry experience will also be considered
• Proven expertise in managing internal and external drug substance development at CDMOs
• Experienced in using DoE methodology for process development
• Proven experience in authoring relevant drug substance sections for regulatory filings - IND, NDA, IMPD, PAS covering preclinical and clinical phases for US and ex-US regions
• Must be hands-on, detail oriented - used to small, startup environments!

Contact:

For a confidential discussion, reach out to Amit at [email protected].