Your 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 process including selection appropriate packaging (container closure systems) for Relay's pipeline products. You will be leading and managing the outsourcing (formulation / product development and manufacturing) activities at global CRO/CMO sites, in alignment with program goals. You will manage prototype development/feasibility assessment and clinical manufacturing activities. You will 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. You will 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. You will draft, review and approve specifications, batch records and other critical development and GMP documents. You will 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. You will 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).You will evaluate and implement new and sustainable drug product technologies for Relay's pipeline products and life-cycle management, as applicable.
Your Background/Qualifications:
Advanced degree (doctoral or post-doctoral degree in Pharmaceutics, Pharmaceutical Sciences or related fields) and minimum of 8-10 years of relevant industry experience with 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. Experience with palatability assessment, taste masking and in-use stability/food-compatibility is desirable. 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 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 a number of factors, including but not limited to, a candidate's education, experience, skills and location.#BP1About 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, and they are 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. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
