Senior Manager, Drug Product

The Opportunity:

• You will be an integral part of Relay’s drug product development team supporting Relay's development programs.
• You will be responsible for design and development of robust, scalable drug product formulation and manufacturing processes that ensure product quality and are commercially viable.
• You will be overseeing technical activities at drug product CMOs, including technology transfer, clinical trial material (CTM) production, process troubleshooting, QbD and PAR studies, risk assessments, registration batch production, and process validation

Your Role:

• You will manage requisite formulation and process development (R&D) activities to support clinical development Relay pipeline programs.
• You will be responsible for assessing and selecting appropriate packaging (container closure systems) for Relay’s development products.
• You will design and develop robust R&D and GMP stability studies for investigational drug products in collaboration with internal AD/QC team and third parties.
• You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and supporting documentation in timely manner.
• You will coordinate with analytical, quality and supply chain teams to ensure timely manufacture and release of drug product batches by leading technical reviews of batch records, deviations, change controls, and nonconformance investigations; proactively identify and mitigate risks related to clinical supply.
• You will partner with drug substance and analytical development functions to define optimal drug substance properties and control strategies.
• You will provide person-in-plant support for drug product manufacturing activities at third parties.
• You will monitor, evaluate completion of tasks and projects, present summaries/updates for upper management.
• You will evaluate and implement new and sustainable drug product technologies for Relay’s pipeline products and life-cycle management, as applicable.

Your Background:

• Master’s or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 6+ years of relevant experience in formulation, product / process development and optimization / scale-up with a focus preferably on CMC for small molecules and oral solid products.
• Experience in authoring CMC Modules 2 & 3 sections for NDAs/MAAs is highly preferred.
• Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD.
• Excellent understanding of the fundamentals / phase appropriate formulation and manufacturing process development along with overall pharmaceutical product development process is a requisite.
• Expertise in development of immediate release oral solid dosage forms (capsules, tablets) is must; experience in injectable product development is a plus.
• 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 and experience in pharmaceutical development of new chemical entities under GMP.
• Knowledge of CMC quality guidelines (particularly US, EU, JP and ICH guidelines).
• Ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Exceptional attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties. 
• Proven ability to collaborate effectively across internal and external stakeholders.
• Excellent written and verbal communication skills with strong problem-solving capabilities.

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