<p>Associate Director - Oral Formulation Development</p> <p>Location: East Bay, California</p> <p>Compensation: $166,000-$190,000 base salary + 15% bonus target</p> <p>HireMinds is partnered with a well-funded, clinical-stage biotech company in the East Bay, CA area 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. You'll have experience in devising plans to transfer from Pre-IND phased to clinical/manufacturing for oral drug products in this role and experience in choosing and running external CMO partnerships.</p> <p>Responsibilities:</p> <ul> <li> <p>Lead oral peptide formulation development from candidate nomination through clinical stages, including lab-based development and tech transfer.</p> </li><li> <p>Mentor junior formulation/pre-formulation scientists and oversee outsourced formulation and testing activities transferred to CMO/CDMO partners.</p> </li><li> <p>Manage preformulation activities and ensure smooth technology transfer to CDMOs.</p> </li><li> <p>Oversee CDMO partnerships for clinical supply manufacturing and regulatory submissions (INDs/NDAs).</p> </li><li> <p>Drive formulation strategy in collaboration with internal R&D, analytical, and manufacturing teams.</p> </li><li> <p>Represent the formulation function on cross-functional project teams.</p> </li><li> <p>Author and review relevant sections of regulatory documents (INDs, NDAs, IMPDs).</p> </li><li> <p>Ensure alignment with regulatory and quality standards across formulation and manufacturing efforts.</p> </li></ul> <p>Qualifications:</p> <ul> <li> <p>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 preference for Biotech company experience.</p> </li><li> <p>Proven leadership and mentoring experience exhibited in industry settings of Formulation activities of orally delivered molecules.</p> </li><li> <p>Strong knowledge of cGMP principles and CDMO management.</p> </li><li> <p>Technical expertise in oral dosage form development, preformulation, and analytical techniques (e.g., HPLC, DSC, TGA, PXRD, FT-IR, particle size analysis).</p> </li><li> <p>Familiarity with advanced oral drug delivery strategies, especially for enhancing peptide bioavailability.</p> </li><li> <p>Excellent communication skills and the ability to thrive in a fast-paced, cross-functional environment.</p> </li><li></li></ul>