Associate Director, Drug Substance & Manufacturing (Late-Stage)
About The Position
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.
Requirements
- M.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.
Nice To Haves
- Experience contributing to NDA/MAA filings preferred.
Responsibilities
- 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.
Benefits
- Unlimited PTO
- Lifestyle spending account
- Commuting reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
