Associate Director, Drug Product Development

Key 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, including review and approval of batch records, campaign plans, protocols, reports, and investigations as applicable
• Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges, ensuring timely resolution of technical issues
• Contribute to the development of process validation strategies for drug product manufacturing in collaboration with internal and external stakeholders
• Oversee preparation, review, and approval of process validation documentation, including process performance qualification (PPQ) protocols/reports, risk assessments, control strategies, and continued process verification plans
• Evaluate manufacturing performance data to identify trends, process capability concerns, and opportunities for continuous improvement
• Lead secondary packaging development activities for a drug product in late-stage development
• Support development of packaging design, component selection, labeling configuration inputs, packaging line considerations, and secondary packaging validation activities with external partners and internal stakeholders

Required Qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline
• 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions
• Demonstrated experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment
• Strong working knowledge of:
• cGMP requirements for OSD manufacturing
• Drug product process development, formulation development, tech transfer, scale-up, and PPQ
• ICH Q8/Q9/Q10 and risk-based validation principles
• 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 related to drug product manufacturing
• Familiarity with statistical tools used for data analysis
• Prior experience in a virtual or highly outsourced biotech environment

Pay

The starting base pay range for this position is $150,000.00-$202,351.00, with compensation determined based on several factors including skill set, years of experience, and geographic location.

Benefits

The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!