Scientist, Small Molecule Drug Product Development & Manufacturing

Summary

This role leads formulation and process development for drug candidates, including prototype design, tech transfer, and GMP manufacturing. It requires collaboration across teams, strong technical skills in oral formulations and analytics, and the ability to manage multiple projects efficiently.

Responsibilities

• Conduct pre-formulation and formulation development activities to support early development candidate selection, which include PK studies, non-GLP and GLP studies.
• Lead formulation development activities, including formulation prototype development, process development, in-vitro dissolution, and stability studies.
• Work with external manufacturing CMOs to enable tech transfer and implementation of drug product manufacturing process and GMP manufacturing.
• Under the guidance of the hiring manager in the drug product development group, help implement and maintain a state-of-the-art drug product development laboratory.
• Author and review technical protocols, development reports, GMP documentation such as manufacturing batch records.
• Responsible for technical leadership towards key formulation decision as part of the overall selection process for advancing molecule for development.
• Represent drug product group in core team meeting and develop strategy with other functions to prioritize and meet CMC deliverables.
• Interact effectively & build successful relationships with members of the drug product group, and with other Arcus stakeholders (Drug Substance, Quality, Analytical Development, Regulatory, Medicinal Chemistry, Clinical Operations & Discovery Biology).
• Consistently seek out, recognize and assess new technologies, and implement such for efficient, reliable & robust drug product development.

Qualifications

• M.S