Senior Commercial Drug Substance Manufacturing Manager
Exelixis
August 12, 2026
On-site
Alameda, CA
Operations
SUMMARY / JOB PURPOSE
This role supports Exelixis small molecule drug substance commercial and clinical manufacturing pipeline. Acts as principal point of contact for technical/operational oversight of DS processes at CMOs and leads DS manufacturing efforts at CMOs, including process changes/optimizations, qualifications, validations, and commercial production.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Oversee API and raw materials third-party manufacturers and test labs; ensure adherence to Exelixis requirements.
- Lead onboarding and qualification of new raw materials suppliers.
- Plan and facilitate business review meetings with CMOs tracking manufacturing and quality performance.
- Ensure on-time execution and compliance with technical, quality, and regulatory requirements.
- Partner with internal teams (logistics, legal, QA, finance, planning) to support a robust supply chain.
- Provide third-party oversight of commercial API manufacturing to meet cGMP quality/compliance standards.
- Review/approve drug substance batch documents; track manufacturing performance (deviations, batch record comments, data trending, yields).
- Perform executed batch record review for disposition.
- Enable process validation (protocols, cleaning validation, master batch records, change controls) with PSC Analytical and GMP QA.
- Drive process improvements and scale-up; approve change controls.
- Support regulatory submissions (write/review sections; may prepare NDA/MAA/IND sections).
- Serve as internal technical SME for troubleshooting and assessments.
QUALIFICATIONS / EXPERIENCE
- BS/BA (organic chemistry/chemical engineering or related) + 9 years; or MS/MA + 7 years; or Ph.D. + 2 years; or equivalent.
- 12+ years in cGMP pharma/biotech manufacturing; 8+ years in commercial small-molecule API manufacturing.
- 2+ years managing CMOs (preferred); strong CMO/regulatory/quality compliance experience.
- Experience in North America/EU/Asia CMOs; process optimization, troubleshooting, change/deviation management; technology transfer.
- Experience with process development, characterization, and validation.
SKILLS
- Strong regulatory/compliance knowledge; technical knowledge of raw materials/API manufacturing.
- Data analysis; scientific software experience.
- Clear written/verbal communication; strong interpersonal skills; Word/Excel/PowerPoint proficiency.
BENEFITS
- 401k with generous company contributions; group medical/dental/vision; life/disability; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive if field sales); company stock; long-term incentives.
- 15 vacation days (first year); 17 paid holidays (incl. winter shutdown in December); up to 10 sick days.
APPLICATION INSTRUCTIONS
- Email ApplicantAccommodations@exelixis.com for recruiting-process disability accommodations.
This role supports Exelixis small molecule drug substance commercial and clinical manufacturing pipeline. Acts as principal point of contact for technical/operational oversight of DS processes at CMOs and leads DS manufacturing efforts at CMOs, including process changes/optimizations, qualifications, validations, and commercial production.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Oversee API and raw materials third-party manufacturers and test labs; ensure adherence to Exelixis requirements.
- Lead onboarding and qualification of new raw materials suppliers.
- Plan and facilitate business review meetings with CMOs tracking manufacturing and quality performance.
- Ensure on-time execution and compliance with technical, quality, and regulatory requirements.
- Partner with internal teams (logistics, legal, QA, finance, planning) to support a robust supply chain.
- Provide third-party oversight of commercial API manufacturing to meet cGMP quality/compliance standards.
- Review/approve drug substance batch documents; track manufacturing performance (deviations, batch record comments, data trending, yields).
- Perform executed batch record review for disposition.
- Enable process validation (protocols, cleaning validation, master batch records, change controls) with PSC Analytical and GMP QA.
- Drive process improvements and scale-up; approve change controls.
- Support regulatory submissions (write/review sections; may prepare NDA/MAA/IND sections).
- Serve as internal technical SME for troubleshooting and assessments.
QUALIFICATIONS / EXPERIENCE
- BS/BA (organic chemistry/chemical engineering or related) + 9 years; or MS/MA + 7 years; or Ph.D. + 2 years; or equivalent.
- 12+ years in cGMP pharma/biotech manufacturing; 8+ years in commercial small-molecule API manufacturing.
- 2+ years managing CMOs (preferred); strong CMO/regulatory/quality compliance experience.
- Experience in North America/EU/Asia CMOs; process optimization, troubleshooting, change/deviation management; technology transfer.
- Experience with process development, characterization, and validation.
SKILLS
- Strong regulatory/compliance knowledge; technical knowledge of raw materials/API manufacturing.
- Data analysis; scientific software experience.
- Clear written/verbal communication; strong interpersonal skills; Word/Excel/PowerPoint proficiency.
BENEFITS
- 401k with generous company contributions; group medical/dental/vision; life/disability; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive if field sales); company stock; long-term incentives.
- 15 vacation days (first year); 17 paid holidays (incl. winter shutdown in December); up to 10 sick days.
APPLICATION INSTRUCTIONS
- Email ApplicantAccommodations@exelixis.com for recruiting-process disability accommodations.