Relay Therapeutics

Senior Manager, Drug Product

Cambridge, MA · Senior

Sponsorship not specified$122k-$174kDetected 57 days ago

Supply ChainGMPCommunicationCollaborationProblem Solving

About the role

You will be an integral part of Relay's drug product development team supporting Relay's development programs.
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
You will be responsible for assessing and selecting appropriate packaging (container closure systems) for Relay's development products.

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 manage requisite formulation and process development (R&D) activities to support clinical development Relay pipeline programs.
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 partner with drug substance and analytical development functions to define optimal drug substance and control strategies.
You will provide person-in-plant support for drug product manufacturing activities at third parties.
Experience and knowledge in identifying critical process parameters (CPPs), design space, design of experiments (DoE) and handling statistical programs commonly used in pharmaceutical industry.

ability to work individually and within multi-disciplinary internal and external teams at third parties.

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.
Knowledge of current Good Manufacturing Practices and experience in pharmaceutical development of new chemical entities under GMP.

Excellent written and verbal communication skills with strong problem-solving capabilities.

Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
[$122,000-$174,000].

This listing is sourced directly from Relay Therapeutics's careers page and normalized into a canonical job model.