Associate Director – Oral Formulation Development

Location: East Bay, California

Compensation: $166,000–$190,000 base salary + 15% bonus target

HireMinds is partnered with a well-funded, clinical-stage biotech company in the East Bay, CA seeking an Associate Director of Oral Formulation Development. This is a hands-on leadership role where you'll guide oral drug product development across a robust drug pipeline, working with a dedicated team of experienced drug developers.

Responsibilities:

• Lead oral peptide formulation development from candidate nomination through clinical stages, including lab-based development and tech transfer.
• Mentor junior formulation scientists and oversee outsourced formulation and testing activities transferred to CMO/CDMO partners.
• Manage preformulation activities and ensure smooth technology transfer to CDMOs.
• Oversee CDMO partnerships for clinical supply manufacturing and regulatory submissions (INDs/NDAs).
• Drive formulation strategy in collaboration with internal R&D, analytical, and manufacturing teams.
• Represent the formulation function on cross-functional project teams.
• Author and review relevant sections of regulatory documents (INDs, NDAs, IMPDs).
• Ensure alignment with regulatory and quality standards across formulation and manufacturing efforts.

Qualifications:

• MS or PhD in Pharmaceutical Sciences, Chemistry, or a related field with 10+ years of experience in formulation development of oral small molecule or peptide drug product development.
• Proven leadership and mentoring experience exhibited in industry settings.
• Strong knowledge of cGMP principles and CDMO management.
• Technical expertise in oral dosage form development, preformulation, and analytical techniques (e.g., HPLC, DSC, TGA, PXRD, FT-IR, particle size analysis).
• Familiarity with advanced oral drug delivery strategies, especially for enhancing peptide bioavailability.
• Excellent communication skills and the ability to thrive in a fast-paced, cross-functional environment.