- 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.
- 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 MT specialist, when required
- This position can be a designee for the Manufacturing Technology Associate Director (Packaging).
- 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.
- A bility to work on own and as part of a team and to drive issues to resolution.
- A 3 rd level degree in science or a related field with a minimum of 7-10 years relevant experience .
- Proven record in pharmaceutical packaging technology, technology transfer, process development and packaging support/activities.
- Strong negotiation capability and ability to manage complex stakeholder networks
- Ability to understand business implications of technical decisions.
- Ability to interact at all levels of the organization with proven influencing ability e.g. Regulatory, CMO etc to achieve goals.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.