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.
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