Associate Director/Director, Drug Product Development (Small-Molecule Pharmaceuticals)

Location: Hybrid in Thousand Oaks or San Francisco, California, United States; approximately 20% domestic and international travel required.

Company

hirify.global is a biotechnology company developing small-molecule pharmaceutical programs.

What you will do

• Lead drug product development strategy and execution from candidate selection through clinical development, registration, commercialization, and launch readiness.
• Direct formulation and process development, scale-up, process characterization, stability programs, batch planning, and product and process control strategies.
• Lead technology transfer, engineering and registration campaigns, process performance qualification, continued process verification, and manufacturing support with CDMOs and CMOs.
• Author and critically review drug product sections of INDs, IMPDs, NDAs, MAAs, Module 3.2.P submissions, briefing documents, and post-approval filings.
• Support interactions with FDA, EMA, MHRA, and PMDA, including inspection and pre-approval inspection readiness.
• Coordinate with Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical, Supply Chain, Project Management, Finance, and external partners while mentoring scientists and managing technical scope, budgets, timelines, and governance.

Requirements

• D. or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline, with 10–15 years of relevant pharmaceutical or biotechnology industry experience.
• Demonstrated leadership of drug product activities for one or more development programs and cross-functional CMC or program teams.
• Strong hands-on and technical oversight experience in formulation and process optimization, scale-up, technology transfer, process characterization, PPQ or process validation, stability, control strategy development, and manufacturing support.
• Experience authoring or critically reviewing drug product regulatory submissions, particularly Module 3.2.P, and responding to health-authority questions.
• Strong expertise in oral solid dosage forms, including tablets and capsules.
• Experience with amorphous or other enabling formulation technologies for low-solubility compounds, such as solid dispersions, spray drying, hot-melt extrusion, or comparable approaches.
• Strong working knowledge of Quality by Design, pharmaceutical development risk management, cGMP requirements, and relevant global or ICH quality guidance.
• Demonstrated success managing CDMO or CMO activities, technical deliverables, budgets, schedules, and cross-functional interfaces in a fast-paced development environment.
• Ability to solve complex technical problems independently, apply sound scientific judgment, communicate clearly, and influence across functions and organizational levels.

Nice to have

• Experience with parenteral formulations, sterile product development, or associated manufacturing controls.

Culture & Benefits

• Hybrid work based in Thousand Oaks or San Francisco, California.
• Approximately 20% travel to partner sites, manufacturing facilities, and regulatory meetings, including domestic and international travel.
• Opportunity to work in a growing biotechnology environment across internal functions and external development and manufacturing partners.