Senior Drug Substance Manufacturing & CMO Delivery Lead

Exelixis Inc; Alameda (CA); On-site; USD 160,000 - 214,000; Full time

Job summary

Exelixis Inc. seeks an experienced leader to oversee the Drug Substance (DS) manufacturing for both commercial and clinical pipelines. You will direct third-party manufacturers and CMOs, ensuring adherence to cGMP and regulatory requirements, while guiding process changes, tech transfers, and validations.

The role requires deep experience with DS manufacturing, QA collaboration, and supplier qualification. You will participate in regulatory documentation and support batch disposition targets

Qualifications

• BS/BA in organic chemistry, chemical engineering, or related field with broad pharma manufacturing experience.
• Nine+ years in cGMP pharmaceutical/biotech manufacturing environment with API/drug substance focus.
• Experience managing CMOs and regulatory/compliance in commercial manufacturing.

Responsibilities

• Oversee API and raw material third-party manufacturers and labs for commercial DS.
• Lead onboarding and qualification of new raw materials suppliers.
• Manage batch document review and disposition for DS manufacturing.
• Approve change controls and support regulatory submissions.
• Collaborate with QA, logistics, legal, and planning to ensure robust supply chain.

Skills

cGMP knowledge

Process optimization

Technology transfer

Deviations management

Communication

Education

BS/BA in chemistry or chemical engineering

MS/MA in related discipline

PhD in related discipline

Tools

Word

Excel

PowerPoint

Job description

Exelixis Inc. seeks an experienced leader to oversee the Drug Substance (DS) manufacturing for both commercial and clinical pipelines. You will direct third-party manufacturers and CMOs, ensuring adherence to cGMP and regulatory requirements, while guiding process changes, tech transfers, and validations.

The role requires deep experience with DS manufacturing, QA collaboration, and supplier qualification. You will participate in regulatory documentation and support batch disposition targets