Senior Drug Substance Manufacturing & CMO Lead

Exelixis; Alameda (CA); On-site; USD 151,000 - 214,000; Full time

Job summary

Exelixis in Alameda, CA is seeking a Drug Substance (DS) Manufacturing Lead to oversee API and raw materials third-party manufacturers for our commercial and clinical drug substance pipeline. You will guide CMOs on process changes, qualifications, validations, and technology transfers to ensure on-time, compliant production.

The role requires extensive cGMP experience, strong collaboration with QA/legal/finance, and oversight of batch documentation, deviations, and data trending.

Qualifications

• BS/BA degree in organic chemistry, chemical engineering, or related discipline with nine years of related experience.
• MS/MA degree in a related discipline with seven years of related experience.
• Ph.D. in related discipline with two years of related experience.
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Twelve years of experience in a cGMP pharmaceutical/biotech manufacturing environment.
• Eight years in commercial small molecule API manufacturing operations.
• Two years managing CMOs preferred.
• Experience with CMOs in North America, EU, and Asia is highly desired.
• Strong organic chemistry or chemical engineering skills with process optimization, troubleshooting, change, and deviation management.
• Experience in technology transfer, process development, process characterization, and process validation.
• Knowledge of regulatory and quality compliance in commercial manufacturing.

Responsibilities

• Support API and raw materials third-party manufacturers and test labs for Exelixis commercial drug substance with strong technical oversight.
• Oversee API and raw material third-party manufacturers and labs to ensure adherence to Exelixis requirements.
• Lead onboarding and qualification of new raw materials suppliers.
• Plan business review meetings with CMOs to track manufacturing and quality performance.
• Work hands-on with CMOs to ensure on-time production per technical, quality, and regulatory requirements.
• Collaborate with logistics, legal, QA, finance, and planning to ensure robust Drug Substance and Raw Materials supply chain.
• Provide third-party oversight of commercial API manufacturing operations to meet cGMP standards.
• Review and approve batch documents for drug substance manufacturing.
• Track manufacturing performance including deviations, batch record comments, data trending, and batch yields.
• Enable process validation through reviews of validation protocols and change controls with cross-functional teams.
• Propose process improvements and scale-up initiatives with DS team.
• Approve change controls with stakeholder input.
• Prepare and facilitate business review meetings between Exelixis and CMOs.
• Contribute to regulatory submissions by writing/reg- sections; possible NDAs/MAAs/INDs.

Skills

Process optimization

Troubleshooting

Change control

Deviation management

Technology transfer

Regulatory compliance

Cross-functional collaboration

Education

BS/BA in chemistry/engineering

MS/MA in related field

PhD in related field

Equivalent education/experience

Professional certification

Job description

Exelixis in Alameda, CA is seeking a Drug Substance (DS) Manufacturing Lead to oversee API and raw materials third-party manufacturers for our commercial and clinical drug substance pipeline. You will guide CMOs on process changes, qualifications, validations, and technology transfers to ensure on-time, compliant production.

The role requires extensive cGMP experience, strong collaboration with QA/legal/finance, and oversight of batch documentation, deviations, and data trending.