Commercial Drug Product Packaging Director

Role Summary

The Commercial Drug Product Packaging Director leads all commercial packaging operations and oversees packaging processes across the Exelixis CMO network. The role requires strong technical expertise in primary and secondary packaging, including labeling and serialization for oral solid dosage forms, and collaboration with internal and external stakeholders to achieve department and company goals.

Responsibilities

• Develop robust processes and systems for oversight of packaging operations at Exelixis CMO network.
• Lead all aspects of commercial packaging operations at CMOs.
• Lead external tech transfers for commercial packaging operations.
• Serve as the Subject Matter Expert for packaging of oral solid dosage products at Contract Manufacturing Organizations.
• Act as the on-site point of contact to manage critical packaging operations at CMOs as needed.
• Provide on-site technical support during project activities such as implementation/qualification of new packaging line equipment and component changes.
• Collaborate with Quality colleagues to drive CMO deviations and investigations to resolution.
• Troubleshoot packaging process issues with technical expertise.
• Be the SME for serialization implementation and ongoing support at CMOs.
• Review and approve Master Packaging Records and executed packaging batch records, protocols, and reports.
• Understand regulatory strategy related to packaging changes.
• Monitor packaging performance (deviations, batch record review timelines) and propose process improvements for efficiency.
• Implement internal department SOPs to ensure well-documented production oversight at CMOs.

Qualifications

• Bachelor’s degree in a related discipline with a minimum of 13 years of related experience; or Master’s degree with a minimum of 11 years of related experience; or equivalent combination of education and experience.
• Extensive experience troubleshooting packaging process issues and leading investigations related to packaging operations.
• Experience providing on-site technical support at CMOs, including oversight of packaging issues and investigations.
• Experience collaborating with internal and external partners, domestically and internationally.
• Experience with packaging artwork review and approval.
• Experience overseeing serialization implementation including validation and communication qualification.

Skills

• Expert knowledge of oral solid dosage packaging operations (bottles and blister) including bottle filling, blistering, cartooning, printing and serialization.
• Ability to apply creativity and provide expert skills to contribute to Exelixis’ portfolio of small molecule commercial products.
• Ability to identify and implement methods, techniques, procedures and evaluation criteria to achieve results.
• Experience leading or managing others in a matrix environment, with responsibility for outcomes, costs, methods and staffing.
• Strong analytical and business communication skills, with the ability to present data clearly to relevant audiences.
• Proficiency with MS Office and specialized applications as needed.
• Thorough understanding of cGMP and regulatory strategy for manufacturing changes (SUPAC, ICH, CFRs).

Education

• Bachelor’s degree in a related discipline; advanced degree preferred.

Additional Requirements

• Travel: 15% of domestic/international travel required.