Associate Director, Drug Product

About the role

You will be the lead and an integral part of Relay’s drug product development team supporting development programs. You will be responsible for design, development, and optimization of patient-centric (e.g., pediatric) drug product formulation and clinical/commercially viable manufacturing processes, including selection of appropriate packaging (container closure systems) for Relay’s pipeline products.

• Lead and manage outsourcing (formulation/product development and manufacturing) activities at global CRO/CMO sites, in alignment with program goals.
• Manage prototype development/feasibility assessment and clinical manufacturing activities.
• Support current and/or plan formulation/drug product R&D and GMP stability studies in collaboration with internal AD/QC, QA teams, and third parties.
• Serve as a key drug product subject matter expert (SME) for successful execution of technology transfer of drug product processes to manufacturing sites, providing technical inputs/insights to Relay’s CMOs.
• Draft, review, and approve specifications, batch records, and other critical development and GMP documents.
• Author, review, and ensure completion of drug product sections of CMC-regulatory submission documents (IND, IMPD, NDA, PIP, iPSP, briefing packages, etc.), responses to regulatory questions, and supporting documentation in a timely manner.
• Act as a key member of Relay’s cross-functional teams, working collaboratively to meet program/project objectives and key results (OKRs).
• Evaluate and implement new and sustainable drug product technologies for Relay’s pipeline products and life-cycle management, as applicable.

Requirements

• Advanced degree (doctoral or post-doctoral degree in Pharmaceutics, Pharmaceutical Sciences, or related fields) and a minimum of 8-10 years of relevant industry experience with a proven track record in oral solids (granules, minitablets, sprinkles/powders for reconstitution, capsules), liquid suspension formulations, manufacturing process development, and optimization/scale-up.
• Understanding of pediatric product development with a focus on selection of excipients, dosage form, and packaging configuration for pediatric populations.
• Experience with palatability assessment, taste masking, and in-use stability/food-compatibility is desirable.
• Excellent understanding of phase-appropriate immediate-release (IR) oral formulations and manufacturing process development, along with the overall pharmaceutical product development process.
• Experience and knowledge in identifying critical process parameters (CPPs), design space, design of experiments (DoE), and handling statistical programs commonly used in the pharmaceutical industry.
• Knowledge of current Good Manufacturing Practices (cGMP) and experience in pharmaceutical development of new chemical entities under cGMP.
• Knowledge of CMC quality guidelines (particularly US, EU, JP, and ICH guidelines) relevant to oral solid drug product development.
• Ability to author and review technical reports to support IND/NDA submission, regulatory compliance, and IP requirements.
• Exceptional organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivation, and ability to work under pressure.
• Demonstrated strategic thinking capabilities with a forward-looking perspective, ability to find solutions in alignment with management and program goals, strong communication, leadership, planning, and collaboration skills.
• Exceptional attention to detail, follow-up/through skills, and ability to work individually and within multi-disciplinary internal and external teams at third parties.

Pay

Estimated salary range: $143,000 – $203,000. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on factors including, but not limited to, a candidate’s education, experience, skills, and location.

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments.