Associate Director, Drug Substance & Manufacturing (Late-Stage)
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Lead late-stage small molecule drug substance development focusing on Phase 3 clinical supply, registration, and lifecycle management. Manage technical interfaces with CDMOs to ensure process robustness, impurity control, and regulatory compliance for NDA/MAA submissions.
Requirements
Requires an MS or PhD in Process Chemistry, Organic Chemistry, or Chemical Engineering with 8-10+ years of experience in small molecule DS development. Must have expertise in DoE, CPV, and familiarity with ICH guidelines and outsourced CDMO management.
Full job description
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 in primary generalized tonic-clonic seizures (PGTCS) 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
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.
Serve as day‑to‑day technical interface with DS and starting‑material CDMOs, including review of batch records, deviations, and change controls.
Must-Haves:
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.
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 $195,000 to $215,000. 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.
Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
Precision medicines to match the complexity of the human brain.
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2022
Headquarters
Boston, Massachusetts
LinkedIn followers
16,214
Total funding
$500M
Rapport Therapeutics aims to transform the treatment of neurological disorders through a precision medicine approach, precisely targeting disease-driving neurocircuits by leveraging receptor-associated proteins (RAPs). With this approach, Rapport can overcome the well-established limitations of today’s neuromedicines that act indiscriminately throughout the nervous system, resulting in suboptimal efficacy and burdensome side effects. Leading the hunt for precision medicines is a team with established track records of innovation in neuroscience and drug discovery. Rapport was conceptualized and created through a partnership between Third Rock Ventures and Johnson & Johnson Innovation-JJDC, Inc. (JJDC) and launched in March 2023. Rapport is based in San Diego, CA and Boston, MA. For more information, please visit www.rapportrx.com.
Offices: Boston, Massachusetts, US · San Diego, California , US
Health CareBiotechnologyLife ScienceMedicalPrecision MedicineNeuroscience
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