Job Details

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 Director of Formulation Development to lead from early through late stage drug product development CROs/CDMOs. This is an ideal opportunity for someone who is seeking a small biotech environment in an expansive CMC role developing programs at multiple phases.

Responsibilities:

• Lead on formulation development and drug product manufacturing at external CROs/CDMOs for peptides and small molecules
• Select, evaluate, and manage CDMO vendors, acting as the CDMO site lead for oral drug product from early through late stage
• Author relevant sections of regulatory filings such as INDs/IMPDs/NDAs
• Advance state-of-the-art drug delivery techniques for oral peptides

Requirements:

• MS/PhD or equivalent in a relevant scientific discipline and 10+ years of industry experience in solid oral dosage formulation development
• Proven expertise in managing internal and external drug product development and manufacturing at CDMOs/CROs
• Experienced in authoring relevant drug product sections for regulatory filings - IND, IMPD, NDA - covering preclinical and clinical phases
• Must be hands-on, detail oriented - used to small, startup environments!

Contact:

For a confidential discussion, reach out to Amit at ...@meetlifesciences.com.