Associate Director, Chemical Development (Biotechnology)

Location: Brisbane, California, United States; up to 50% domestic and international travel required, varying by project needs.

Salary: $243,410.16–$256,800 per year; base salary is $243,410.16, with higher compensation potentially available based on skills and experience.

Company

Biotechnology organization developing pharmaceutical products from drug discovery through clinical development and commercialization.

What you will do

• Lead regulatory starting material and drug substance cGMP manufacturing activities from preclinical development through commercialization.
• Identify, select, and manage US and international contract manufacturing organizations for process optimization and cGMP drug substance manufacturing.
• Develop scalable, cost-effective, phase-appropriate manufacturing processes that meet quality and regulatory requirements.
• Lead QbD process characterization, design of experiments, critical quality attribute and critical process parameter assessment, and drug substance control strategy development.
• Manage drug substance stability, process validation, supply-chain, and logistics programs supporting clinical and commercial demand.
• Prepare and review CMC documentation, regulatory submissions, batch records, technical reports, publications, and presentations; represent the drug substance function before US and European regulatory authorities.

Requirements

• PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or a related scientific discipline.
• At least 5 years of industry experience in a pharmaceutical or biotechnology CMC/cGMP environment.
• Experience developing safe, scalable, phase-appropriate synthesis routes to drug substance targets.
• Experience overseeing US and international contract manufacturing organizations producing cGMP new chemical entity drug substances.
• Experience authoring Module 3 sections for IND/IMPD and/or NDA/MAA filings.
• Knowledge of ICH Q7, FDA 21 CFR Parts 210 and 211, and EU GMP Volume 4 Parts I and II.

Culture & Benefits

• Work supports pharmaceutical development across discovery, clinical programs, and commercialization.
• Role includes collaboration with CROs, CMOs, quality functions, and regulatory authorities.
• Domestic and foreign travel may comprise up to 50% of the role based on project requirements.