Commercial Drug Product Packaging Director

SUMMARY/JOB PURPOSE (Basic purpose of the job):

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:

• Directing work at external CMO's, Consultants or 3rd party.
• Manages others in a matrix environment (dotted line reporting).

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor's degree in related discipline and a minimum of 13 years of related experience; or,
• Master's degree in related discipline and a minimum of 11 years of related experience; or,
• Equivalent combination of education and experience.

Experience:

• Extensive experience in troubleshooting packaging process issues, as well as participating in and leading investigations associated with packaging operations.
• Experience providing CMO on-site technical support, including oversight of packaging issues and investigations.
• Experience working with internal and external partners, both domestic and international.
• Experience with packaging artwork review and approval.
• Experience overseeing serialization implementation including validation and communications qualification.

Knowledge, Skills and Abilities:

• Demonstrates expert knowledge of oral solid dosage packaging operations (bottles and blister) including bottle filling and blistering, cartooning, printing and serialization.
• Applies creativity, innovation and expert skills to contribute to Exelixis portfolio of small molecule commercial products.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques related to oral solid dose packaging.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills, be able to present data and results concisely per relevant audience.
• Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
• Thorough understanding of cGMP and regulatory strategy associated with manufacturing changes including SUPAC, ICH and CFR's.
• Environment: primarily working in laboratories or in office.
• Travel required - 15% of domestic/international travel required.

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster 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.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.