Director, Pharmaceutical Development (Biotech)

Location: On site in the Brisbane, California office; primarily office and laboratory based, with occasional GMP manufacturing facility access and approximately 25% domestic and international travel.

Salary: $218,000–$260,000 per year.

Company

Clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases with an AI-integrated discovery engine.

What you will do

• Lead QbD-based formulation and process development for small molecule oral and topical dosage forms across all development phases.
• Develop enabling formulations, including amorphous solid dispersions, lipid-based delivery systems, and nano-formulations to address solubility and bioavailability challenges.
• Define QTPPs and CQAs, assess CMAs and CPPs using FMEA and other risk tools, and establish robust control strategies.
• Lead scale-up, process optimization, technology transfer, PPQ, CPV, and troubleshooting of manufacturing deviations and failures.
• Author and review CMC sections for IND, NDA, MAA, and CTD regulatory submissions.
• Manage CDMO partnerships and provide technical leadership across Analytical Development, Clinical Operations, Regulatory Affairs, Quality, Supply Chain, and Commercial functions.

Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a closely related discipline strongly preferred.
• At least 12 years of progressive pharmaceutical development experience in biotechnology, pharmaceutical, or CDMO settings.
• Deep experience with small molecule drug products, oral and topical dosage forms, enabled formulation development, and BCS Class II/IV compounds.
• Hands-on expertise in QbD, including QTPP, CQA, CMA/CPP risk assessment, DoE, design space development, and control strategy establishment.
• Significant Phase 2b/3 and late-stage development experience, including NDA/MAA submissions and responses to agency queries.
• Demonstrated people management, strategic planning, budget and resource ownership, CDMO oversight, and ability to gown for cleanroom/GMP environments.

Culture & Benefits

• Strong team orientation and highly collaborative working style.
• Solutions- and results-oriented approach.
• Hands-on, resourceful environment open to diverse points of view.
• Approximately 25% travel to CDMO sites, clinical manufacturing sites, regulatory agency meetings, and scientific conferences.