Associate Director, Drug Substance & Manufacturing (Late-Stage)

This role is based in Boston, MA with onsite presence required Monday-Wednesday

Your impact:

Rapport is seeking a highly motivated Associate Director to join its CMC (Chemistry, Manufacturing, and Controls) team. This role will focus on late stage small molecule Drug Substance development, including Phase 3 clinical supply, registration, and lifecycle management, with an emphasis on process robustness, starting material strategy, impurity control, and continued process verification. The position will support process characterization (including DoE), CPV program implementation, and regulatory ready control strategies to ensure reliable clinical and commercial supply in collaboration with internal teams and external CDMOs.

Your day-to-day:

• Support lifecycle management of Phase‑appropriate to commercial DS processes, ensuring robustness and scalability.
• Support manufacturing, sourcing, and control of starting materials and key intermediates.
• Ensure alignment between starting material controls, impurity strategy, and DS control strategy.
• Design and support DoE and process characterization studies to establish CPPs, NORs, and control strategies.
• Translate process understanding into defensible control strategies for NDA/MAA submissions and inspections.
• Support comparability assessments for process, scale, or site changes.
• Support establishment and execution of CPV programs for DS manufacturing.
• Support impurity fate and purge, GTI/nitrosamine risk assessments, and specification justification.
• Maintain control of solid‑state form and physical attributes to ensure DP and commercial alignment.
• Support late‑stage CMC regulatory content (IND updates, NDA/MAA Module 3 –2.S).
• Serve as day‑to‑day technical interface with DS and starting‑material CDMOs, including review of batch records, deviations, and change controls.

Must-Haves:

• S. or Ph.D. in Process Chemistry, Organic Chemistry, or Chemical Engineering.
• 8+ years (Ph.D.) or 10+ years (M.S.) experience in small molecule DS development, with late stage or registration exposure.
• Experience with RSM strategy, DoE/process characterization, and CPV.
• Familiarity with ICH Q7-Q12, Q3A/C/D, and M7.
• Experience working with outsourced CDMOs.
• Experience contributing to NDA/MAA filings preferred.

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.