This role is based in Boston, MA with onsite presence required Monday-Wednesday
Your impact: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.
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.
Must-Haves:- 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:We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $190,000 to $210,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Hybrid Work Environment:We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.
