Associate Director, Drug Product

The role

You will lead drug product development and manage outsourcing activities at global CRO/CMO sites. You will design and optimize patient-centric drug product formulations and manufacturing processes for Relay's pipeline.

What you will do

• Design, develop and optimize patient-centric drug product formulation and manufacturing processes.
• Select appropriate packaging for pipeline products.
• Lead and manage outsourcing activities at global CRO/CMO sites.
• Manage prototype development, feasibility assessment and clinical manufacturing activities.
• Support formulation and drug product R&D and GMP stability studies.
• Provide technical inputs for technology transfer of drug product processes to manufacturing sites.
• Draft, review and approve specifications, batch records and other critical development and GMP documents.
• Author and review drug product sections of CMC-regulatory submission documents.
• Work collaboratively in cross-functional teams to meet program objectives.
• Evaluate and implement new drug product technologies for pipeline products and life-cycle management.

Required qualifications

• Advanced degree (doctoral or post-doctoral degree in Pharmaceutics, Pharmaceutical Sciences or related fields).
• Minimum of 8-10 years of relevant industry experience with proven-track record in oral solids, liquid suspension formulations, manufacturing process development and optimization/scale-up.
• Understanding of basics/fundamentals of pediatric product development with focus on selection of excipients, dosage form and packaging configuration for pediatric population.
• Excellent understanding of phase-appropriate IR oral formulations and manufacturing process development along with overall pharmaceutical product development process.
• Experience and knowledge in identifying critical process parameters (CPPs), design space, design of experiments (DoE) and handling statistical programs.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Experience in pharmaceutical development of new chemical entities under cGMP.
• Knowledge of CMC quality guidelines (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.
• Organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Strategic thinking capabilities, communication, leadership, planning, and collaboration skills.
• Attention to detail and ability to work individually and within multi-disciplinary internal and external teams.

Nice to have

• Experience with palatability assessment, taste masking and in-use stability/food-compatibility is desirable.

About the company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. They use a Dynamo platform to integrate experimental and computational approaches to drug protein targets.