Associate Director, Drug Product Development

Responsibilities

• Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities
• Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation
• Provide technical leadership for clinical and commercial drug product manufacturing campaigns
• Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges
• Contribute to the development of process validation strategies for drug product manufacturing
• Oversee preparation, review, and approval of process validation documentation
• Evaluate manufacturing performance data to identify trends and opportunities for continuous improvement
• Lead secondary packaging development activities for a drug product in late-stage development

Requirements

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline
• 10+ years of experience in pharmaceutical drug product development, manufacturing science, or technical operations
• Experience supporting outsourced manufacturing models and managing CDMOs
• Strong knowledge of cGMP requirements for OSD manufacturing
• Expertise in drug product process development, formulation, tech transfer, scale-up, and PPQ
• Knowledge of ICH Q8/Q9/Q10 and risk-based validation principles
• Experience with manufacturing investigations and change management

Preferred Qualifications

• Experience supporting regulatory submissions and PAIs for solid oral dosage products
• Experience with lifecycle management, CPV programs, and post-approval change management
• Experience authoring or reviewing CMC sections for regulatory submissions
• Familiarity with statistical tools for data analysis
• Prior experience in a virtual or highly outsourced biotech environment

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave