Senior Packaging Manager

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

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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.

*…