Principal Scientist, Small Molecule Analytical Sciences

Arcus Biosciences•Hayward, CA

9d•Onsite

About The Position

We seek a strong technical problem solver and decision maker to join our analytical team and help us achieve our goals for NDA readiness. This onsite role will be a key contributor to Arcus’ Pharmaceutical Development & Manufacturing organization. You are a hands-on expert in HPLC method development and mass spectrometry, self-starter and finisher, organized and detail-oriented, and strong verbal and written communicator. Prior work experience in CMC analytical for new molecular entities in innovator companies, as well as a willingness to own, adapt, and learn, are essential to this role.

Requirements

PhD with 5+ years of relevant work experience; or MS with 7+ years of relevant work experience; or BS with 9+ years of relevant work experience
Relevant work experience in CMC analytical development in innovator company that develops new molecular entities (clinical to commercial filing phase), including understanding of cGMPs, phase-appropriate practices, and ICH guidelines
Expertise in HPLC method development, mass spectrometry, and other techniques used in small molecule testing (e.g., GC, dissolution, Karl Fischer)
Ability to clearly and effectively elaborate technical concepts in presentations and reports
Awareness of timelines and integration of when deliverables need to begin and be completed

Responsibilities

Method development, impurity characterization, experimental design, and testing in Arcus’ well-appointed analytical laboratory
Management of CDMO/CRO testing (release, stability, method validation/transfer)
Collaboration with drug substance and drug product development colleagues
Documentation (electronic notebooks, authoring technical reports)
Opportunities for analytical lead responsibility in CMC teams, regulatory filing authorship, and personnel management, as commensurate with experience and business needs