Principal Scientist, Small-Molecule Drug Substance Development and Manufacturing

Arcus Biosciences (https://arcusbio.com/) is a biotech company focused on immuno-oncology with clinical stage drug candidates in both monoclonal antibody and small molecule areas. Our Small Molecule Drug Substance Development and Manufacturing team has an opportunity for a Principal Scientist position to support our small molecule drug development pipeline.

Responsibilities

• Be a passionate, creative, and collaborative member of the Small Molecule Dug Substance Development and Manufacturing team that strives to create the best manufacturing process to support Arcus small molecule pipeline from preclinical development to commercial launch.
• Develop efficient, phase appropriate synthetic processes for APIs through effective lab scale R&D, which will include but not limited to route design, route scouting and process optimization toward suitable API synthesis for development and commercial production.  Design and execute critical experiments to trouble shoot process issues encountered in large scale productions.  Conduct lab experiments such as the establishment of process ranges, impurity fate and purges to support process characterization and process validation for late-stage projects.
• Work in a team of Arcus scientists and partner contract development and manufacturing organization teams to develop efficient manufacturing processes for small molecule drug substance preparation under GMP.  The projects may encompass clinical stage candidates through commercial launch. Responsibilities will range from initiating process transfer, through scale up, GMP manufacturing and process validation activities.
• Help manage process chemistry and GMP manufacturing efforts at CROs/CMOs and the sourcing of related raw materials and intermediates. Provide technical review of master batch records. Manage part of a project such as an individual GMP step or GMP starting material manufacturing with minimal management supervision.
• Provide person-in-plant support for manufacturing at CMO sites as needed by traveling either domestically or overseas.
• Provide concise technical updates to the Small Molecule Dug Substance Development and Manufacturing organization and key stakeholders in partner functions.
• Partner with Drug Product, Analytical Sciences, Quality Control and Quality Assurance to help ensure Arcus’ manufactured GMP drug substances are delivered on time with appropriate quality.
• Contribute to writing / reviewing CMC sections of regulatory filings as needed.

Qualifications

• Ph.D. in Organic Chemistry or related field. 
• 6+ years (M.S. with 9+ years or B.S. with 12+ years) of relevant experience in the biotech/pharmaceutical industry.
• Expert knowledge of process chemistry, synthetic organic chemistry, analytical methods (NMR, MS and HPLC) and physic