Oral Drug Product Formulation & Development Lead

12-month W-2 contract with potential to convert

A clinical-stage biotechnology company is seeking an experienced CMC professional to lead oral drug-product formulation and development activities across its peptide portfolio. This person will take hands-on ownership of external development programs and manage CDMO partners through formulation, process development, scale-up, technology transfer, and GMP manufacturing.

Key responsibilities

• Lead oral solid-dose formulation and process development, particularly for oral peptide/tablet products.
• Manage CDMOs across the United States, Europe, and China.
• Oversee scale-up, technology transfer, clinical manufacturing, and GMP readiness.
• Establish development plans, timelines, technical strategy, and deliverables.
• Troubleshoot formulation, manufacturing, and process-development challenges.
• Coordinate with internal CMC, analytical, quality, regulatory, and supply-chain stakeholders.
• Hold external partners accountable for timelines, quality, and execution.
• Provide hands-on operational ownership rather than functioning solely as an advisor.

Ideal background

• Approximately 12+ years of pharmaceutical or biotechnology industry experience.
• Strong oral drug-product and oral solid-dose experience.
• Direct peptide formulation experience strongly preferred.
• Experience with tablets and enabling technologies for oral peptide delivery.
• Demonstrated success managing CDMOs and external development programs.
• Experience with formulation development, scale-up, technology transfer, and GMP manufacturing.
• Comfortable working in a fast-moving, lean biotechnology environment.
• Bay Area or west coast presence preferred.
• Flexibility for domestic and international travel required.