About the position
Arcus Biosciences 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 Senior Scientist position to support our small molecule drug development pipeline. Under supervision of a senior member of the team to contribute to the overall business goals of Small Molecule Drug Substance Development & Manufacturing. 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. Provide technical review of master batch records. 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 Drug 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.
Responsibilities
- Develop efficient, phase appropriate synthetic processes for APIs through effective lab scale R&D.
- Design and execute critical experiments to troubleshoot 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.
- Initiate process transfer, scale up, GMP manufacturing and process validation activities.
- Provide technical review of master batch records.
- Provide person-in-plant support for manufacturing at CMO sites as needed.
- Provide concise technical updates to the Small Molecule Drug Substance Development and Manufacturing organization and key stakeholders.
- Partner with Drug Product, Analytical Sciences, Quality Control and Quality Assurance to ensure timely delivery of GMP drug substances.
- Contribute to writing/reviewing CMC sections of regulatory filings as needed.
Requirements
- Ph.D. in Organic Chemistry with at least 3 years of related industry experience, or MS with 6 years or B.S. with 8 years of related industry experience.
- Well trained in modern synthetic organic chemistry, including synthetic methodology, reaction mechanism, and modern analytical methods (NMR, MS and HPLC).
- Proven ability to carry out independent in-depth research in the areas of design and implementation of efficient synthetic routes for complex target organic compounds and/or development of new synthetic methodologies.
- Established track record for strategic thinking and creative problem solving.
- Excellent interpersonal skills, including clear, succinct, and timely oral and written communications.
- Proven ability to foster collaborative relationships with key stakeholders.
- Excellent organizational skills, with ability to successfully manage multiple priorities.
- Full knowledge and firsthand experiences in small molecule drug substance manufacturing under GMP regulations.
Nice-to-haves
- A good publication record is desirable.
- Late-stage process characterization work experiences to support NDA filing such as process range finding, impurity fate and purges, technical report writing to support NDA filing are highly preferred.
Benefits
- Competitive market-based salary.
- Opportunity to participate in stock programs.
- Performance-based bonus.
- Comprehensive benefits package.
