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Salary: USD 143,000 - 203,000 / annual
Relay Therapeutics seeks an Associate Director of Drug Product to lead formulation development and manufacturing strategy for its precision medicine pipeline. You will own design, development, and optimization of patient-centric drug product formulations (with pediatric focus), clinical and commercial manufacturing processes, and container-closure systems. Key responsibilities include managing outsourcing relationships with global CROs/CMOs, overseeing prototype development and clinical manufacturing, supporting GMP stability studies, and serving as the technical subject matter expert for technology transfer to manufacturing partners.
You will draft and approve critical development and GMP documentation, author drug product sections of regulatory submissions (IND, IMPD, NDA, PIP, iPSP), and respond to regulatory questions. You'll collaborate cross-functionally to meet program objectives and evaluate new, sustainable drug product technologies for pipeline products and lifecycle management.
The ideal candidate holds a doctoral or post-doctoral degree in Pharmaceutics or Pharmaceutical Sciences with 8–10 years of industry experience in oral solids (granules, minitablets, sprinkles, capsules), liquid suspensions, and manufacturing process development/scale-up. You must understand pediatric product development fundamentals, including excipient selection, dosage form design, and packaging for pediatric populations. Experience with palatability assessment, taste masking, and in-use stability is desirable.
You should have strong knowledge of phase-appropriate IR oral formulations, critical process parameters (CPPs), design space, design of experiments (DoE), cGMP, and CMC quality guidelines (US, EU, JP, ICH). Exceptional organizational skills, strategic thinking, problem-solving, and the ability to author technical reports for regulatory compliance are essential. You'll work individually and within multidisciplinary internal and external teams, demonstrating strong communication, leadership, and collaboration skills.
