Associate Director, Drug Product

Relay Therapeutics•Cambridge, MA

5d•$143,000 - $203,000

About The Position

This role is for an Associate Director of Drug Product at Relay Therapeutics, a clinical-stage precision medicines company. The individual will be an integral part of the drug product development team, supporting development programs. Responsibilities include the design, development, and optimization of patient-centric drug product formulations and manufacturing processes, including packaging selection. The role involves leading and managing outsourcing activities at global CRO/CMO sites, managing prototype development, feasibility assessments, and clinical manufacturing. The position also requires supporting R&D and GMP stability studies, acting as a subject matter expert for technology transfer, drafting and reviewing critical documents, and authoring drug product sections for regulatory submissions. The Associate Director will be a key member of cross-functional teams, evaluating and implementing new drug product technologies, and contributing to the company's goal of bringing life-changing therapies to patients.

Requirements

Advanced degree (doctoral or post-doctoral degree in Pharmaceutics, Pharmaceutical Sciences or related fields)
Minimum of 8-10 years of relevant industry experience
Proven track-record in oral solids (granules, minitablets, sprinkles/powders for reconstitution, capsules), liquid suspension formulations, manufacturing process development and optimization / scale-up thereof.
Understanding of basics / fundamentals of pediatric product development with focus on selection of excipients, dosage form and packaging configuration for pediatric population.
Excellent understanding of the phase-appropriate IR oral formulations and manufacturing process development along with overall pharmaceutical product development process is a requisite.
Experience and knowledge in identifying critical process parameters (CPPs), design space, design of experiments (DoE) and handling statistical programs commonly used in 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, 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-motivated and able to work under pressure.
Demonstrated strategic thinking capabilities with forward looking perspective and 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; ability to work individually and within multi-disciplinary internal and external teams at third parties

Nice To Haves

Experience with palatability assessment, taste masking and in-use stability/food-compatibility is desirable.

Responsibilities

Lead and be an integral part of Relay’s drug product development team supporting development programs.
Responsible for design, development and optimization of patient-centric drug product formulation and clinical / commercially viable manufacturing process including selection 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.
Be a key drug product SME for successful execution of the technology transfer of drug product processes to manufacturing site(s), providing technical in-puts / insights to the 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 providing supporting documentation, in a timely manner.
Be an asset and key member of Relay’s cross-functional teams and work collaboratively to meet the 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.