Commercial Drug Product Packaging Director
Exelixis
2 days ago
On-site
Alameda, CA
$166,500 - $236,500 USD yearly
Operations
Responsibilities:
- Develop robust processes and systems for oversight of commercial packaging operations across the Exelixis CMO network.
- Lead all aspects of commercial packaging operations at CMOs.
- Lead external tech transfers for commercial packaging operations.
- Serve as Subject Matter Expert (SME) for oral solid dosage packaging at CMOs.
- Act as “person in plant” as needed to manage critical packaging operations at CMOs.
- Provide on-site technical support for implementation/qualification of new packaging line equipment and component changes.
- Partner with Quality colleagues to drive CMO deviations and investigations to resolution.
- Troubleshoot packaging process issues.
- Serve as 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 for packaging changes.
- Track and monitor packaging performance (e.g., deviations, batch record review timelines) and propose process improvements.
- Implement internal department SOPs to ensure well-documented CMO production oversight.
Supervisory Responsibilities:
- Direct work at external CMOs, consultants, or third parties.
- Manage others in a matrix environment (dotted line reporting).
Education/Experience (Required):
- Bachelor’s degree in a related discipline and minimum 13 years of related experience; or
- Master’s degree in a related discipline and minimum 11 years of related experience; or
- Equivalent combination of education and experience.
Experience:
- Extensive experience troubleshooting packaging process issues and leading/participating in packaging investigations.
- Experience providing on-site CMO technical support.
- Experience working with internal/external partners (domestic and international).
- Experience reviewing and approving packaging artwork.
- Serialization implementation experience, including validation and communications qualification.
Skills/Qualifications:
- Expert knowledge of oral solid dosage packaging (bottles and blister): bottle filling/blistering, cartooning, printing, and serialization.
- Strong technical principles applied to oral solid dose packaging.
- Strong analytical and business communication skills; ability to present results clearly.
- Proficient with MS Office and specialized job applications.
- Thorough understanding of cGMP and regulatory strategy for manufacturing changes (e.g., SUPAC, ICH, CFRs).
- Travel required: ~15% domestic/international.
Benefits:
- 401(k) with company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase and long-term incentives.
- 15 vacation days (first year); 17 paid holidays (including winter shutdown in December); up to 10 sick days.
Work Environment:
- Primarily laboratories or office; open-plan office setting with collaborative workspace.
- Develop robust processes and systems for oversight of commercial packaging operations across the Exelixis CMO network.
- Lead all aspects of commercial packaging operations at CMOs.
- Lead external tech transfers for commercial packaging operations.
- Serve as Subject Matter Expert (SME) for oral solid dosage packaging at CMOs.
- Act as “person in plant” as needed to manage critical packaging operations at CMOs.
- Provide on-site technical support for implementation/qualification of new packaging line equipment and component changes.
- Partner with Quality colleagues to drive CMO deviations and investigations to resolution.
- Troubleshoot packaging process issues.
- Serve as 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 for packaging changes.
- Track and monitor packaging performance (e.g., deviations, batch record review timelines) and propose process improvements.
- Implement internal department SOPs to ensure well-documented CMO production oversight.
Supervisory Responsibilities:
- Direct work at external CMOs, consultants, or third parties.
- Manage others in a matrix environment (dotted line reporting).
Education/Experience (Required):
- Bachelor’s degree in a related discipline and minimum 13 years of related experience; or
- Master’s degree in a related discipline and minimum 11 years of related experience; or
- Equivalent combination of education and experience.
Experience:
- Extensive experience troubleshooting packaging process issues and leading/participating in packaging investigations.
- Experience providing on-site CMO technical support.
- Experience working with internal/external partners (domestic and international).
- Experience reviewing and approving packaging artwork.
- Serialization implementation experience, including validation and communications qualification.
Skills/Qualifications:
- Expert knowledge of oral solid dosage packaging (bottles and blister): bottle filling/blistering, cartooning, printing, and serialization.
- Strong technical principles applied to oral solid dose packaging.
- Strong analytical and business communication skills; ability to present results clearly.
- Proficient with MS Office and specialized job applications.
- Thorough understanding of cGMP and regulatory strategy for manufacturing changes (e.g., SUPAC, ICH, CFRs).
- Travel required: ~15% domestic/international.
Benefits:
- 401(k) with company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase and long-term incentives.
- 15 vacation days (first year); 17 paid holidays (including winter shutdown in December); up to 10 sick days.
Work Environment:
- Primarily laboratories or office; open-plan office setting with collaborative workspace.