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, including 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.
• Help implement and maintain a state-of-the-art drug product development laboratory.
• Author and review technical protocols, development reports, and GMP documentation such as manufacturing batch records.
• Provide technical leadership towards key formulation decisions as part of the overall selection process for advancing molecules for development.
• Represent drug product group in core team meetings and develop strategy with other functions to prioritize and meet CMC deliverables.
• Interact effectively and build successful relationships with members of the drug product group and 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 and robust drug product development.

Qualifications

• M.S. or PhD in Chemical Engineering or Pharmaceutical Sciences (or related discipline) with 1-2+ years of relevant industry experience.
• Experienced in oral formulation development, drug product process development, and technology transfer.
• Experience with analytical techniques for small molecules such as HPLC, DSC, TGA, XRPD, and other advanced formulation scientific equipment.
• High degree of flexibility and organizational skills with eagerness and ability to learn.
• Strong interpersonal skills with ability to communicate effectively both verbally and in written formats.
• Detail oriented, rigorous and excellent skills in record keeping/documentation.
• Experience in laboratory implementation and management is preferred.
• Proven ability to think creatively and obtain solutions to complex and diverse problems.