Associate Director, Drug Product Development

Responsibilities

• Your day-to-day:
• Late-Stage Development & Commercialization
• 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.
• Process Characterization, Validation & Continued Verification
• 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.
• External Collaboration & CDMO Oversight
• Manage CDMOs supporting late-stage and commercial supply.
• Ensure alignment with validation and regulatory strategies.
• Oversee lifecycle management activities externally.
• Cross-Functional Leadership
• Collaborate with Analytical, Quality, Regulatory, and Supply Chain.
• Ensure alignment of development and commercial strategy.
• Support lifecycle and post-approval changes.

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
• What makes Rapport special:
• Every role has meaning. We're determined to discover a better way for patients, and you'll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas - we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you'll enjoy spending time with.
• Leadership that CARES - about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston - we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.
• Your Compensation:

Benefits

Additional Information

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder. The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are! This role is based in Boston, MA with onsite presence required Monday-Wednesday

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