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 :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

Experience :

Knowledge, Skills and Abilities :

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.

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

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $166,500 - $236,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.