Packaging Manager
Location:
Posted:
October 01, 2016
Reference:
1603988
Description:
  • 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).



Qualifications:
Qualifications/Experience:
  • 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 Characterisation/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 organisation 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.

Know someone who would be interested in this job? Share it with your network.