Senior Process Chemist, Drug Substance Development

Exelixis Inc; Alameda (CA); On-site; USD 133,000 - 188,000; Full time

Benefits offered by this job

401k plan

Medical/Dental/Vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Exelixis Inc. is seeking a Senior Scientist II, Process Chemistry to advance small-molecule drug substance development from early development through commercialization. You will execute process development in-house and support technology transfer and CDMO manufacturing.

The role requires leading synthetic route evaluation, impurity characterization, and cross-functional collaboration, with responsibility for regulatory documentation and batch transfer packages.

Qualifications

• Bachelor’s, Master’s, or PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science, or related field with 9/7/2+ years in biotech/pharma
• Demonstrated track record in process chemistry and scalable drug-substance development
• Experience with analytical methods (NMR, MS, HPLC) and impurity profiling

Responsibilities

• Evaluate synthetic routes and enable scale-up of drug substances and intermediates
• Develop safe, phase-appropriate processes in-house or at CDMOs
• Characterize process impurities and establish impurity control strategies
• Support scale-up and manufacturing for preclinical/clinical studies
• Prepare technical packages for process transfer to CDMO facilities
• Collaborate with CDMOs to meet technical, quality, and regulatory requirements
• Prepare/review drug substance manufacturing batch documents
• Assist regulatory submissions by drafting relevant sections
• Serve as internal SME for troubleshooting and assessments

Skills

Process chemistry

Analytical methods

NMR

MS

HPLC

Cross-functional teamwork

CDMO experience

Education

Bachelor’s degree in Organic Chemistry or related

Master’s degree in Organic Chemistry or related

PhD in Organic Chemistry or related

Tools

CDMO collaboration tools

Job description

Exelixis Inc. is seeking a Senior Scientist II, Process Chemistry to advance small-molecule drug substance development from early development through commercialization. You will execute process development in-house and support technology transfer and CDMO manufacturing.

The role requires leading synthetic route evaluation, impurity characterization, and cross-functional collaboration, with responsibility for regulatory documentation and batch transfer packages.