Associate Director, Commercial Manufacturing & Packaging

Role: Associate Director of Commercial Manufacturing overseeing global drug product manufacturing and packaging for rare disease therapies. Objectives include ensuring continuous, compliant supply by managing manufacturing planning, CMO governance, validation, technology transfer, and supply-risk mitigation. Responsibilities encompass coordinating manufacturing activities at CMOs, developing schedules based on sales forecasts, verifying process qualification, supporting troubleshooting, maintaining GMP compliance, representing manufacturing in due diligence and regulatory interactions, and authoring technical reports. Qualifications: Bachelor's in Process/Chemical Engineering or related field; 8+ years leading pharmaceutical manufacturing, including process troubleshooting and optimization; experience with multiple dosage forms, preferably oral solid dosage. Skills include process validation, project management, risk mitigation, and strong communication. Preferences: familiarity with US/EU GMP standards, complex project management, and international travel (up to 10%). Sector specifics: biologic or small molecule manufacturing for rare disease therapies, with involvement in regulatory submissions and audits. Work setup: remote with face-to-face collaboration in San Diego; travel required.