Senior Packaging Manager
About The Position
This position plays a key role in pharmaceutical packaging as a member of cross-functional development programs supporting projects from concept through commercialization. The role involves providing Packaging technical support to the External Manufacturing Organization (ExM) and Contract Manufacturing Organizations (CMOs), ensuring the transfer of robust Primary and Secondary Drug Product Packaging processes to CMOs. The Senior Packaging Manager will assess and maintain robust packaging process performance at CMOs for the primary and secondary packaging of BMS products, actively working to continuously reduce supply risks associated with packaging operations and processes. This role requires maintaining current knowledge of primary and secondary packaging types/technology, packaging processes, packaging equipment, and serialization to support the successful operation of the ExM business unit.
Requirements
- Bachelors (or Masters) degree in science, engineering, packaging or a related field with a minimum of 6 years relevant experience.
- Proven record in pharmaceutical packaging technology, technology transfer, process development and packaging support/activities.
- Ability to interact at all levels of the organization with proven influencing ability e.g. Regulatory, CMO etc to achieve goals.
- Strong negotiation capability and ability to manage complex stakeholder networks.
- Ability to understand business implications of technical decisions.
- Must have in-depth knowledge of primary packaging processes, and process equipment for OSD blister packaging (PVC/Alu, Alu/Alu, Aclar/Alu) and HDPE/LDPE bottles and associated sealing; sterile and nonsterile liquids and semisolids (bottle filling, vial filling, tubes).
- Knowledge of Characterization/Analytical Techniques for measuring critical quality attributes of packaging materials.
- Experience of methods for optimum primary and secondary packaging assessment.
- In-depth knowledge of the regulatory standards and compliance expectations for such processes.
- Knowledge of serialization requirements and serialization technology.
- Experienced with use of statistical software to analyze process related data to determine process capability or for troubleshooting purposes.
- Proficient in the technical transfer of packaging processes to CMOs within budget and according to project timeline.
- Demonstrated ability to manage one or more tech transfer projects with minimal supervision.
- Excellent verbal, written communications and presentations skills, including excellence at concise writing of complex study plans and scientific reports; informing diverse stakeholder groups about the critical issues related to packaging processes when required.
- Ability to work on own and as part of a team and to drive issues to resolution.
Responsibilities
- Support CMO selection process – compilation of technical packages, due diligence and completing scoring.
- Leads packaging robustness assessment and improvement initiatives.
- Accountable for/Leading technology transfer packaging projects, ensuring robust technical transfer within budget constraints, and completing associated regulatory filings.
- Support operational management of packaging CMOs as per Supplier Relationship Management governance model.
- Provide on-going technical support to ExM / CMO to ensure compliance and security of supply – metrics review, deviation closure, CAPA effectiveness, change control review, APQR review, process improvement.
- Identify and Implement OPEX initiatives as necessary.
- Leads process investigations when required, using structured root cause analysis tools.
- Represents Manufacturing Technology on project teams and works closely with Supply Relationship Manager and project team members.
- Product robustness - technical lead for creation of process robustness monitoring plan, process control strategy, and provides technical oversight of TPM sites to ensure continuous process monitoring for all products in scope.
- Supervise work of MS&T specialist(s), when required.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires with manager approval
- 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
