Associate Director, Drug Product Development

This is a fully remote position, open to applicants in New York.

📋 Description

• Act as the primary technical liaison for CDMOs involved in drug product manufacturing and release processes.

• Lead the oversight of drug product development initiatives, encompassing process development, technology transfer, scale-up, and validation.

• Provide technical guidance for both clinical and commercial drug product manufacturing campaigns, which includes the evaluation and approval of batch records, campaign plans, protocols, reports, and investigations as necessary.

• Collaborate with CDMOs to identify, evaluate, and mitigate process risks and manufacturing challenges, ensuring the prompt resolution of technical issues.

• Contribute to the formulation of process validation strategies for drug product manufacturing in partnership with both internal and external stakeholders.

• Supervise the preparation, review, and approval of process validation documentation, including process performance qualification (PPQ) protocols/reports, risk assessments, control strategies, and continued process verification plans.

• Analyze manufacturing performance data to detect trends, process capability issues, and opportunities for continuous improvement.

• Direct secondary packaging development activities for a drug product that is in late-stage development.

• Assist in the development of packaging design, component selection, labeling configurations, packaging line considerations, and secondary packaging validation activities in collaboration with external partners and internal stakeholders.

⛳️ Requirements

• A degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related field.

• Over 10 years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions.

• Proven experience in supporting outsourced manufacturing models and managing CDMOs within a virtual company environment.

• Strong working knowledge of:

• cGMP requirements for OSD manufacturing.

• Drug product process development, formulation development, technology transfer, scale-up, and PPQ.

• ICH Q8/Q9/Q10 and risk-based validation principles.

• Manufacturing investigations and change management.

• Demonstrated ability to technically oversee and influence external manufacturing partners.

🏝️ Benefits

• Comprehensive health benefits fully covered, including Medical, Dental, and Vision for you and your dependents.

• 401(k) plan with company matching and vesting starting after the first month following your start date.

• Flexible time off policy.

• Generous parental leave, along with various enjoyable fringe benefits!