Sr Scientist I (Process Chemistry)

Role Summary

The Senior Scientist I, Process Chemistry, will focus mainly on executing in-house process chemistry efforts at Exelixis process research and development lab. This individual will work with medicinal discovery chemist to evaluate synthetic routes for early-stage discovery projects to facilitate smooth scale up for supply of compounds for pre-clinical studies, understand the physical and chemical properties of compounds of interest and perform solid state polymorph screening to define the stable polymorph for DS manufacturing, tech transfer the processes developed in lab to CMO for clinical manufacturing and work with project teams for troubleshooting and problem solving 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.

Qualifications

• 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.

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.