About Relay Therapeutics
Backed by GV and SoftBank VF.
About the role
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.
What they're looking for
- 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
More about this 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...
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