Senior Commercial Drug Substance Manufacturing Manager

About the role

This role supports Exelixis’ small molecule drug substance commercial and clinical manufacturing pipeline as part of a team that oversees the technical and operational performance of Drug Substance (DS) processes at contract manufacturing organizations (CMOs). The position guides and oversees CMO partners in process changes, optimizations, qualifications, validations, and commercial production, while leading change projects, raw materials qualifications, internal investigations, deviations, technology transfers, scale-up, and the transition of projects from development to commercial.

Responsibilities

• Support Exelixis’ Active Pharmaceutical Ingredient (API) and raw materials third-party manufacturers and test labs, ensuring strong technical oversight for commercial drug substance.
• Oversee, track, and manage API and raw material third-party manufacturers and test labs to ensure adherence to Exelixis requirements.
• Lead onboarding and qualification of new raw materials suppliers.
• Plan and facilitate business review meetings with CMOs to track manufacturing and quality performance.
• Work closely with CMOs to ensure production is executed on time and meets technical, quality, and regulatory requirements.
• Collaborate with logistics, legal, QA, finance, and planning teams to integrate Drug Substance and Raw Materials production into a robust supply chain.
• Partner with the quality organization to provide third-party oversight of commercial API manufacturing operations, ensuring cGMP compliance.
• Review and approve batch documents for drug substance manufacturing to meet technical and regulatory requirements.
• Track and monitor manufacturing performance, including deviations, batch record comments, data trending, and batch yields.
• Perform full executed batch record review for intermediate and API batches as part of the disposition process.
• Enable process validation through reviews and approvals of protocols, master batch records, and change controls in coordination with cross-functional teams.
• Propose process improvements and scale-up initiatives to introduce efficiencies.
• Approve change controls using sound scientific understanding and collaboration with key stakeholders.
• Prepare content and facilitate business review meetings between Exelixis and CMOs.
• Contribute to regulatory submissions by writing and reviewing appropriate sections of documents such as NDAs, MAAs, and INDs.
• Act as a technical subject matter expert (SME) for troubleshooting and internal assessments.

Requirements

• BS/BA degree in organic chemistry, chemical engineering, or related discipline and a minimum of nine years of related experience; or,
• MS/MA degree in a related discipline and a minimum of seven years of related experience; or,
• Ph.D. in related discipline and a minimum of two years of related experience; or,
• Equivalent combination of education and experience.
• Minimum of twelve years of experience in a cGMP pharmaceutical/biotech manufacturing environment.
• Minimum of eight years of experience in commercial small molecule active pharmaceutical ingredients manufacturing operations.
• Minimum of two years of experience managing Contract Manufacturing Organizations (CMOs) preferred.
• Track record of working with external contract organizations (CMOs) in a manufacturing role, with thorough understanding of regulatory legislations and quality/compliance in commercial manufacturing.
• Experience working with CMOs in North America, EU, and Asia, including raw materials and Drug Substances.
• Proven expertise in process optimization, troubleshooting, change, and deviation management.
• Experience in process development, process characterization, process validation, and technology transfer.

Skills

• Strong knowledge of regulatory and compliance issues related to commercial Drug Substance manufacturing.
• Technical expertise in raw materials and drug substance manufacturing.
• Excellent data analysis skills and experience with scientific software applications.
• Strong communication, interpersonal, and teamwork skills.
• Self-motivation and ability to work effectively in a fast-paced environment with deadlines.
• Flexibility to adapt to changing priorities and work collaboratively or independently.
• High integrity, creativity, and attention to detail in document review and editing.
• Strong analytical and business communication skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Benefits

• Comprehensive employee benefits package, including a 401k plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program or sales-based incentive plan for field sales staff.
• Opportunity to purchase company stock and receive long-term incentives.
• 15 accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

Pay

The base pay range for this position is $151,000 - $214,000 annually, adjusted for geographic region, job-related knowledge, skills, experience, and internal equity.

Schedule

• 30% domestic travel required.