Commercial Drug Product Packaging Director

Commercial Drug Product Packaging Director

The Commercial Drug Product Packaging Director is responsible for setting up robust processes and systems for oversight of commercial packaging and leads all commercial packaging operations for Exelixis at our growing network of Contract Manufacturing Organizations (CMOs). This position requires a highly motivated individual with excellent interpersonal skills to work effectively in a team-based environment and interface with internal and external stakeholders to execute on department and company goals. This position requires strong technical expertise and demonstrated experience in overseeing all aspects of primary and secondary packaging operations (including labeling and serialization) for oral solid dosage forms.

Essential Duties / Responsibilities :

• Develop robust processes and systems for oversight of packaging operations at Exelixis CMO network.
• Lead all aspects of commercial packaging operations at CMO's.
• Lead external tech transfers for commercial packaging operations.
• Be the Subject Matter Expert (SME) for packaging of oral solid dosage products at Contract Manufacturing Organizations.
• Be the "person in plant" as needed to manage critical packaging operations at CMO's.
• Provide on-site technical support during project activities such as implementation / qualification of new packaging line equipment and introduction of component changes.
• Work closely with Quality colleagues, providing technical expertise to drive CMO deviations and investigations to successful resolution.
• Utilize technical expertise to troubleshoot packaging process issues.
• Be the SME for serialization implementation and ongoing support at CMO's.
• Review and approve Master Packaging Records and executed packaging batch records, protocols, and reports.
• Have a solid understanding of regulatory strategy associated with packaging changes.
• Closely track and monitor packaging performance including packaging deviations, packaging batch record review timelines etc., and propose improvements to processes where efficiencies can be introduced.
• Implement internal department SOPs to ensure that production oversight at CMOs is well documented with the best processes.

Supervisory Responsibilities :

Education / Experience / Knowledge & Skills :

Work Environment / Physical Demands :

Our office is a modern, open-plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.