Senior Packaging Manager

Job Function

• Provide Packaging technical support to the External Manufacturing Organization (ExM) and CMOs
• Ensure the transfer of robust Primary and Secondary Drug Product Packaging processes to Contract Manufacturing Organizations (CMO)
• Assess and maintain robust packaging process performance at CMO for the primary and secondary packaging of BMS products
• Actively works to continuously reduce supply risks associated with packaging operations and processes
• Maintains current knowledge of primary and secondary packaging types/technology, packaging processes, packaging equipment and serialization, to support successful operation of the ExM business unit

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

Education

Bachelors (or Masters) degree in science, engineering, packaging or a related field with a minimum of 6 years relevant experience.

Experience / Knowledge Desired

• 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 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