Associate Director, Drug Product Development
About The Position
Rapport Therapeutics is seeking a highly motivated Associate Director of Drug Product Development to join its CMC (Chemistry, Manufacturing, and Controls) team. This role will focus on late-stage development, NDA submission, and anticipated commercial manufacturing and this individual will lead late-stage drug product execution to ensure robust, scalable, and inspection-ready processes. The ideal candidate will bring deep expertise in process characterization, validation, and commercial control strategies, including establishing Critical Process Parameters (CPPs), Normal Operating Ranges (NORs), and Proven Acceptable Ranges (PARs) to enable successful regulatory approval and reliable commercial supply.
Requirements
- Ph.D. (6–8+ years) or M.S. (10–12+ years) in relevant field.
- Experience in late-stage drug product development (Phase 3–Commercial).
- Expertise in CPPs, CQAs, DoE, NORs, PARs.
- Experience with NDA submissions and approvals.
- Hands-on commercial manufacturing experience.
- Knowledge of ICH Q8–Q11.
- Experience managing CDMOs.
- Strong leadership and communication skills
Responsibilities
- Lead drug product activities through NDA submission, approval, and commercial launch.
- Drive commercial readiness strategies ensuring scalability and supply reliability.
- Define and implement control strategies supporting lifecycle management.
- Author and review NDA CMC sections focusing on validation and control strategy.
- Establish and justify CPPs, CQAs, NORs, and PARs.
- Design and execute DoE studies for process robustness.
- Lead PPQ campaigns and validation execution.
- Implement CPV strategies for commercial processes.
- Manage CDMOs supporting late-stage and commercial supply.
- Ensure alignment with validation and regulatory strategies.
- Oversee lifecycle management activities externally.
- Collaborate with Analytical, Quality, Regulatory, and Supply Chain.
- Ensure alignment of development and commercial strategy.
- Support lifecycle and post-approval changes.
Benefits
- unlimited PTO
- a lifestyle spending account
- commuting reimbursement
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
