Senior Manager, Drug Product

Relay Therapeutics • Cambridge, MA

2d

About The Position

This role is an integral part of Relay’s drug product development team, supporting Relay's development programs. The position is responsible for the design and development of robust, scalable drug product formulation and manufacturing processes that ensure product quality and are commercially viable. The role also involves 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.

Requirements

• 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.
• 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 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.

Nice To Haves

• 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.
• Experience in injectable product development is a plus.

Responsibilities

• Manage requisite formulation and process development (R&D) activities to support clinical development Relay pipeline programs.
• Assess and select appropriate packaging (container closure systems) for Relay’s development products.
• Design and develop robust R&D and GMP stability studies for investigational drug products in collaboration with internal AD/QC team and third parties.
• 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.
• 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.
• Partner with drug substance and analytical development functions to define optimal drug substance properties and control strategies.
• Provide person-in-plant support for drug product manufacturing activities at third parties.
• Monitor, evaluate completion of tasks and projects, present summaries/updates for upper management.
• Evaluate and implement new and sustainable drug product technologies for Relay’s pipeline products and life-cycle management, as applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior