Associate Director, Product Development (San Mateo County)

The Associate Director of Product Development is a critical role that will be responsible for key aspects of pharmaceutical development. The role will focus on phase appropriate product development of surfactant lyophilized formulations, manufacturing process optimization and scale up, and product characterization supporting pre-clinical and clinical studies.

This position will play a central role in establishing and operating in-house development laboratory. The Associate Director will lead hands-on formulation and process development of lipid / peptide formulations, including design, execution, and iteration of experiments. The role requires expertise with lipid-based formulations, lyophilization, protocol development, and cross-functional experimental execution in collaboration with process engineers, analytical scientists, and lab technicians. Once formulations are developed, the Associate Director will conduct product understanding and characterization studies and lead scale-up and technology transfer to CDMOs.

• Education and experience : Ph.D. in Pharmaceutical sciences, Chemical engineering, Biochemical engineering or related field.
• 810 years in lipid formulations, liposomes, or related drug delivery technologies.
• Hands-on experience in formulation and process development, including homogenization and lyophilization.
• Extensive experience working with CDMOs is required.
• Late-stage product development experience is required.
• 25 years of manufacturing process development (lyophilization) is a plus.
• Experience authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a must.
• Knowledge and experience in drug-device development, inhalation drug delivery is a plus.
• Knowledge of Good Manufacturing Practices, ICH, FDA, Health Canada, and MHRA Regulations is required
• Key Responsibilities : Leadership & Strategy : Oversee product development for biologics, proteins, and peptides, managing projects with CDMOs.
• In-House Laboratory Development : Establish and manage a formulation / process development laboratory. Design and execute protocols, perform hands-on formulation and process development, including homogenization and lyophilization of lipid / peptide formulations, and coordinate iterative experimental work with a cross-functional team.
• Product Development : Research, design, and execute controlled experiments, with high attention to detail to develop stable and effective drug products fit for commercialization. Conduct QbD experiments to identify CQAs that impact product performance and stability. Conduct registration-enabling stability studies and product characterization studies per appropriate ICH guidances.
• Product Understanding & Characterization : Lead detailed product characterization studies once lead formulations are developed, ensuring comprehensive product knowledge prior to scale-up.
• CDMO / CMO Collaboration : Serve as the primary liaison with external manufacturing and analytical partners. Ensure effective communication and coordination to meet project timelines and quality expectations.
• Scale-Up & Tech Transfer : Translate laboratory-developed formulations into scalable processes, overseeing transfer to CDMO partners.
• Regulatory Compliance : Prepare and review documentation for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to cGMP and regulatory requirements. Experience authoring late-stage regulatory dossiers, particularly BLAs, is required.
• Cross-Functional Collaboration : Work closely with R&D, Manufacturing, Regulatory, and Quality Assurance teams to integrate product development within overall project goals.
• Troubleshooting & Problem Solving : Address and resolve formulation, process optimization, and analytical issues during development and manufacturing. Implement corrective and preventive actions as needed. ?
• Technical Expertise : Strong hands-on formulation and process development skills, including homogenization and lyophilization. Experience with lipid-based products (including peptides / proteins) is required. Experience with lyophilization manufacturing process development and validation is preferred. Scientific Rigor : Ability to design, execute, and iterate experimental protocols, interpret data, and guide cross-functional teams to advance development.
• Regulatory Knowledge : Deep understanding of regulatory requirements and submission processes for IND and NDA / BLA.
• Leadership Skills : Proven ability to establish and lead lab operations, manage and mentor multidisciplinary teams, and foster effective cross-functional collaboration.
• Results-Oriented : Strong initiative, accountability, and willingness to take ownership and drive projects to completion. Work independently with CDMOs without close supervision.
• Collaboration : Proven ability to operate effectively across a matrix organization to drive programs according to timelines; ability to articulate project objectives and priorities.
• Dynamic Thinking : Sense of urgency and a bias toward action; comfortable challenging the status quo and pushing teams to examine all angles.
• Communication : Strong written and oral communications skills.
• Problem-Solving : Strong analytical skills with a proven track record of overcoming complex scientific challenges.