Sr Scientist I (Process Chemistry)

Role Summary

The Senior Scientist I, Process Chemistry, will execute in-house process chemistry efforts at the Exelixis process research and development laboratory. They will work with medicinal discovery chemists to evaluate synthetic routes for early-stage projects to facilitate scale-up for pre-clinical supply, understand the physical and chemical properties of compounds, and perform solid-state polymorph screening to define stable forms for manufacturing. The role also covers tech transfer of lab-developed processes to CMOs for clinical manufacturing and collaboration with project teams on troubleshooting for ongoing manufacturing projects.

Responsibilities

• Work with discovery teams to evaluate synthetic routes and test alternatives that facilitate scale up of both target compounds and building blocks while providing insights for selection of development candidates.
• Execute in-house process development and optimization studies to facilitate scale up and transfer to CMOs.
• Collaborate with project team to source appropriate starting materials.
• Prepare technical packages for transfer of processes to CMO/CRO partner facilities.
• Knowledge of characterization of the physical and chemical properties of compounds of interest and perform solid state characterization and polymorph screening.
• Partner with Manufacturing, Formulation Development, Analytical Chemistry, Quality Control and Quality Assurance to ensure drug substances are delivered on time and within specification.
• Write and review CMC sections of regulatory filings when needed.
• Keep abreast of all relevant publications and guidance documents.

Education

• Bachelor’s degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 7 years of relevant experience in the biotech/pharmaceutical industry; or,
• Master’s in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 5 years of relevant experience in the biotech/pharmaceutical industry; or,
• PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field with 0 or more years of relevant experience in the biotech/pharmaceutical industry; or,
• Equivalent combination of education and experience.

Skills

• Knowledge of process chemistry, synthetic organic chemistry, analytical methods (especially NMR, MS and HPLC) and physical-chemical characterization of compounds.
• Proven ability to develop, optimize and scale up drug substance manufacturing processes and demonstrated skills to manage GMP contract manufacturing organizations will be a plus.
• Excellent interpersonal skills, oral and written communication skills.
• Excellent organizational skills, with ability to successfully manage multiple priorities.
• Ability to work effectively with cross-functional teams.
• Highly self-motivated and detail-oriented, with proven ability to work independently.