At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Position plays a key role in pharmaceutical packaging as a member of cross-functional development programs supporting projects from concept through commercialization.
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.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
New Brunswick - NJ - US: $123,580 - $149,752