Collins McNicholas

Packaging Manager Role required to support New Product Introductions in Packaging for various technologies. The Packaging Manager role will be the primary point of contact for on the selected projects and will coordinate activities to ensure all deliverables are in place to facilitate a smooth transition to commercial operations. This role will work with various functions to facilitate a smooth transfer from R&D/ GPT to operations for given projects. The Packaging Manager will be responsible for ensuring all GMP activities are assigned to various functions and that timelines are adhered to.

Responsibilities: 

  • Recruitment and development of Biologics Inspection and Packaging Department
  • Develop themselves and their teams as SME on biologics product components, primary container closure, container closure integrity, equipment, automation, data integrity, QRM (CQA’s, CPP’s, CCP’s), cross contamination, coding labelling, thermoform sealing, cartooning, T&T
  • Knowledge on all upstream & downstream processes and impact of subprocess to CQAs, industry complaints, customer, etc
  • High level of input into DFMEA & PFMEAs for facility, equipment and process
  • Challenge of Design documentation to meet QA, OPEX and EHS requirements (URS, ES, DS, SDS, HDS, FSDS, RTM, DQ, Pre-FAT, FAT, SAT). Vendor site visits.
  • Review, approval & execution of validation activity to meet QA, OPEX and EHS requirements (IQ/OQ/PQ/PPQ)
  • Work in conjunction with BCE Trainer on the development of overarching training strategy and roadmap for BCE Operations (Inspection and Packaging)
  • Develop and execute clear action plans to ensure Inspection and Packaging Department is ready for commercial launch per EHS, QA and Opex requirements.
  • Development of process flows, SOPs, risk assessments, training processes, batch records, logbooks and necessary documentation to support a commercial Inspection and Packaging department

Education and Experience

  • MSc degree with three years experience or a degree in a Science or Engineering discipline with five or more years of applied experience in Pharma/ Biologics.
  • Experience with commercial & / or clinical manufacture.
  • Excellent technical writing and communication skills.
  • Proven ability to problem solve.
  • Must be a self-starter with a pro-active approach
  • Experience with interacting in project teams.
  • Experience with packaging technologies
  • Flexibility of working hours may be required
  • Experience with GMP regulatory inspections

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