Principal Scientist / Associate Director, Pharmaceutics at Relay Therapeutics
Cambridge, MA, US

We are seeking a versatile, self-motivated individual to become an integral member of the R&D teams and the Nonclinical Development function for Relay Therapeutics.  You will be responsible for formulation and analytical development, integrating innovative formulation strategies and plans at lead optimization through IND-enabling studies and early clinical development, through an outsourcing approach. We are looking for a consummate team player who seeks a scientifically rigorous and collaborative environment in which to grow their career in drug development.

Your Role

In partnership with Nonclinical leads and project leaders, you will develop CMC plan and timelines for Relay’s discovery and early development programs

You’ll lead establishment and oversight of activities, including formulation development and drug product manufacturing at external laboratories and manufacturing facilities

You will be the functional area representative for Pharmaceutics on project teams

Manage CROs and other vendors, including participation in vendor audits as a CMC expert

Author and review CMC sections of regulatory documents, study reports and other development related documents

Contribute to building and maintaining Quality infrastructure in support of external CMC operations

Your Background

You have a minimum of 7 years of relevant small molecule formulation development and CMC experience in the pharmaceutical industry.  Small molecule oncology experience preferred

M.S. or Ph.D. in Pharmaceutical Sciences or related discipline

You have extensive experience with diverse oral dosage form technologies and implementing both fit-for-purpose and innovative approaches based on program requirements.  You’ll bring your expertise in the interplay between formulation modality, bioavailability and PK/PD

Experience in management of Contract Manufacturing Organizations, leading GMP manufacturing activities, and managing drug supply for clinical studies

You have experience leading formulation development on projects across discovery, preclinical and clinical phases. CMC project leadership experience is a plus

Operational experience and familiarity with the drug development process, including external regulatory requirements

You’ve got excellent communication and organizational skills; you’re comfortable navigating complexity and ambiguity in a fast-paced environment interacting with consultants, external vendors and internal cross-functional project teams.  You also have a track record of achieving results in a virtual/outsourced model

Well versed in authoring and reviewing CMC sections of regulatory dossiers