Senior Process Chemist – Drug Substance Scale-Up

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

Benefits offered by this job

401k plan

Medical, dental, vision insurance

Life and disability insurance

Stock options

Discretionary annual bonus

Vacation and holidays

Job summary

Exelixis, Inc. is seeking a Senior Scientist II in Alameda, CA to lead process chemistry development for small-molecule programs from early development through commercialization. You will evaluate routes, develop phase-appropriate processes, and support CDMOs for scale-up and tech transfer.

The role includes impurity characterization, cross-functional collaboration, and regulatory/documentation support. Domestic travel up to 10% is expected; a competitive base salary and comprehensive benefits

Qualifications

• Bachelor’s degree with 9+ years in biotech/pharma, or equivalent combination.
• Master’s degree with 7+ years in biotech/pharma.
• PhD with 2+ years in biotech/pharma.
• Experience in process chemistry and regulatory-compliant drug substance development.

Responsibilities

• Evaluate synthetic routes and test scale-up of small-molecule drug substances and intermediates.
• Develop safe, phase-appropriate processes in-house or at CDMOs.
• Characterize process impurities and establish impurity control strategies.
• Facilitate scale-up and manufacturing to supply drug substances for preclinical and clinical studies.
• Prepare technical packages for CDMO transfer and serve as SME on cross-functional teams supporting CDMO manufacturing.
• Collaborate with CDMOs to ensure timely production meeting quality and regulatory requirements.
• Prepare and review drug substance manufacturing batch documents for compliance.
• Assist regulatory submissions by drafting sections of NDAs, MMAs, and INDs.
• Travel domestically up to 10%.

Skills

Process chemistry

Synthetic organic chemistry

Analytical methods (NMR, MS, HPLC)

Impurity characterization

CDMO collaboration

Cross-functional teamwork

Domestic travel up to 10%

Education

Bachelor’s degree in Organic Chemistry / Chemical Engineering / Pharmaceutical Science

Master’s degree in Organic Chemistry / Chemical Engineering / Pharmaceutical Science

PhD in Organic Chemistry / Chemical Engineering / Pharmaceutical Science

Job description

Exelixis, Inc. is seeking a Senior Scientist II in Alameda, CA to lead process chemistry development for small-molecule programs from early development through commercialization. You will evaluate routes, develop phase-appropriate processes, and support CDMOs for scale-up and tech transfer.

The role includes impurity characterization, cross-functional collaboration, and regulatory/documentation support. Domestic travel up to 10% is expected; a competitive base salary and comprehensive benefits