Associate Director, Drug Product Development

Overview 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), a component of neuronal receptor complexes that regulate receptor assembly and function. This precision approach has the potential to revolutionize small‑molecule therapy development. Our lead program, RAP‑219, first targets focal epilepsy, with additional trials planned for neuropathic pain and bipolar disorder. The strength of Rapport comes from our Rapptors—united by the mission to improve patients’ lives. We bring heart and hustle to advance our science forward, staying true to our core values. We hope you’re as excited about this opportunity as we are! Location This role is based in Boston, MA with onsite presence required Monday–Wednesday. Your Impact We are seeking a highly motivated Associate Director of Drug Product Development to join our CMC (Chemistry, Manufacturing, and Controls) team. This role focuses on late‑stage development, NDA submission, and anticipated commercial manufacture, leading late‑stage drug product execution to ensure robust, scalable, and inspection‑ready processes. Responsibilities 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. Establish and justify critical process parameters (CPPs), CQAs, normal operating ranges (NORs), and proven acceptable ranges (PARs). Design and execute Design of Experiments (DoE) studies for process robustness. Lead process performance qualification (PPQ) campaigns and validation execution. Implement commercial process verification (CPV) strategies. Manage CDMOs supporting late‑stage and commercial supply, ensuring alignment with validation and regulatory strategies. Oversee lifecycle management activities externally. Collaborate with Analytical, Quality, Regulatory, and Supply Chain teams to align development and commercial strategy. Support lifecycle and post‑approval changes. Qualifications Ph.D. (6–8+ years) or M.S. (10–12+ years) in a relevant scientific field. Experience in late‑stage drug product development (Phase 3 to commercial). Expertise in CPPs, CQAs, DoE, NORs, and 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. Benefits Competitive benefits including unlimited PTO, a lifestyle spending account, commuting reimbursement, and more. Opportunities for meaningful impact in a fast‑moving, innovative environment. Collaborative culture where diverse perspectives are valued. Supportive leadership focused on personal growth and development. Hybrid work environment with onsite collaboration Monday–Wednesday in Boston. Fun and inclusive workplace culture. Compensation The target salary range for this role is $190,000 to $210,000. Final offers will consider relevant skills, experience, location, and market data, supplemented by a competitive benefits package. Hybrid Work Environment We prioritize in‑person connection. Our team members come together onsite at the Boston office Monday–Wednesday to foster innovation, collaboration, and connection. Equal Opportunity Employer 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 unsolicited resumes. CCPA Disclosure CCPA disclosure notice can be found here. #J-18808-Ljbffr Rapport Therapeutics