Commercial Drug Product Packaging Director
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Role Summary
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.
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.
Qualifications
- 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 in troubleshooting packaging process issues, including leading investigations related to 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.
Skills
- Demonstrates expert knowledge of oral solid dosage packaging operations (bottles and blister) including bottle filling and blistering, cartooning, printing and serialization.
- Applied creativity and expert skills to contribute to 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 with responsibility for results, including costs, methods and staffing.
- Performs a variety of complicated tasks with a wide degree of creativity and latitude.
- Complete understanding and wide application of technical principles related to oral solid dose packaging.
- General knowledge of related disciplines.
- Strong analytical and business communication skills; ability to present data and results concisely.
- Proficient with MS Office and specialized applications as needed.
- Understanding of cGMP and regulatory strategy associated with manufacturing changes including SUPAC, ICH and CFRs.
Education
- As listed in Qualifications above.
Additional Requirements
- Travel required – 15% of domestic/international travel required.