Senior Manager, Drug Product

Relay Therapeutics; Cambridge (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Relay Therapeutics is seeking an experienced professional to join their drug product development team in Cambridge, Massachusetts. The role involves overseeing the design and development of drug formulation processes, ensuring product quality, and managing regulatory submissions.

The ideal candidate has a Master’s degree in Pharmaceutical Sciences and over 6 years of experience in formulation and process development, with expertise in authoring regulatory documents.

Apply to become a key player in advancing Relay's drug development programs!

Qualifications

• 6+ years of experience in formulation and process development.
• Experience in authoring CMC Modules for NDAs/MAAs.
• Knowledge of Good Manufacturing Practices in pharmaceutical development.

Responsibilities

• Manage formulation and process development activities.
• Coordinate with analytical and quality teams for timely batch release.
• Contribute to regulatory submission documents and responses.

Skills

Formulation development

Process optimization

Regulatory submissions

Project management

Problem-solving

Education

Master's or advanced degree in Pharmaceutical Sciences

Tools

Design of Experiments (DoE)

Statistical programs

Job description

Your Role

• 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 oversee 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.
• You will manage requisite formulation and process development activities to support clinical development of Relay’s pipeline programs.
• You will assess and select 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 a 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, and 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.

Qualifications and Experience

• 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/reviewing/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 the overall pharmaceutical product development process.
• Expertise in developing immediate‑release oral solid dosage forms (capsules, tablets) is required; 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 the 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.

As set forth in Relay Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.