Associate Director/Director, Drug Product Development

Job Title: Associate Director/Director, Drug Product Development
Location: Thousand Oaks/ San Francisco, CA
Department: CMC
Reports To: Sr. Director, Drug Product

Position Summary:
We are seeking an experienced and execution-oriented Associate Director / Director, Drug Product Development to lead drug product activities for small-molecule programs from candidate selection through clinical development, registration, and commercialization. This individual will provide technical leadership for formulation and process development, clinical and registration supply, technology transfer, process validation, regulatory submissions, and launch readiness. The role requires strong expertise in oral solid dosage forms and practical experience with enabling or amorphous formulation technologies for poorly soluble compounds. Experience with parenteral dosage forms is desirable. The successful candidate will work effectively across internal functions and external development and manufacturing partners in a growing biotechnology environment.

Key Responsibilities:

- Lead drug product development strategy and execution for assigned small-molecule programs, with responsibility spanning formulation and process development, clinical supply, technology transfer, registration-enabling activities, and commercialization.

- Serve as the drug product CMC lead on cross-functional program teams; communicate technical options, risks, dependencies, timelines, and recommendations to CMC and program leadership.

- Plan and oversee formulation and process development, including formulation selection and optimization, process scale-up, process characterization, pivotal and registration batch planning, and registration stability activities.

- Lead or support technology transfer to CDMOs/CMOs, engineering and registration campaigns, process performance qualification (PPQ), continued process verification (CPV), and commercial launch preparation.

- Develop science- and risk-based product and process control strategies, including the quality target product profile, critical quality attributes, material attributes, critical process parameters, in-process controls, specifications, and lifecycle monitoring.

- Provide technical leadership for oral solid dosage forms, including tablets and capsules, and support parenteral dosage forms when applicable. Apply enabling formulation approaches such as amorphous solid dispersions, spray drying, hot-melt extrusion, or comparable technologies for poorly soluble compounds.

- Ensure timely and reliable delivery of clinical, registration, and launch materials through oversight of manufacturing, packaging, container-closure systems, stability programs, investigations, deviations, change controls, and technical risk mitigation.

- Author and critically review drug product sections of global CMC submissions, including INDs, IMPDs, NDAs, MAAs, Module 3.2.P content, briefing documents, responses to information requests, and post-approval submissions.

- Prepare for and support interactions with global health authorities, including FDA, EMA, MHRA, and PMDA, and contribute to inspection and pre-approval inspection readiness.

- Partner with Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical, Clinical Supply, Commercial Manufacturing, Supply Chain, Project Management, and Finance to develop and execute integrated program plans.

- Select and manage CDMOs/CMOs and other external partners; define technical scope, deliverables, timelines, budgets, quality interfaces, governance cadence, and escalation pathways.

- Provide technical guidance and mentorship to scientists and team members. At the Director level, may lead personnel, broader functional initiatives, and resource planning based on organizational needs.

- Contribute to functional standards, technical review practices, development best practices, and knowledge management while maintaining awareness of emerging technologies and evolving regulatory expectations.

Qualifications:

- D. or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline with at least 10-15 years of relevant pharmaceutical or biotechnology industry experience

- Demonstrated ability to lead drug product activities for one or more development programs and to work effectively on 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/process validation, stability, control strategy development, and manufacturing support.

- Experience authoring or critically reviewing drug product sections of regulatory submissions, particularly Module 3.2.P, and supporting responses to health-authority questions.

- Strong expertise in oral solid dosage forms. Experience with parenteral formulations, sterile product development, or associated manufacturing controls is preferred.

- 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/ICH quality guidance.

- Demonstrated success managing CDMO/CMO activities, technical deliverables, budgets, schedules, and cross-functional interfaces in a fast-paced development environment.

- Ability to independently solve complex technical problems, exercise sound scientific judgment, and translate technical information into clear program recommendations.

- Excellent written and verbal communication skills and the ability to influence across functions and organizational levels.

- Willingness to travel approximately 20% of the time, including domestic and international travel to partner sites, manufacturing facilities, and regulatory meetings.