Science Jobs

Associate Director of Formulation (Oral Doseage)

CHEMISTRY - FORMULATION (SCIENCE)
  • Job ID: 19864
  • Direct Hire
  • CA
Email

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.