Process Transfer Manager - Medical Devices 13485

Job Title: Process Transfer Manager - Medical Devices 13485
Contract Type: Permanent
Location: Manchester, Greater Manchester
Salary: Excellent Benefits
Start Date: ASAP
Reference: J895724_1530264452
Contact Name: Lauren Ellis
Contact Email:
Job Published: June 29, 2018 10:27

Job Description

Our Client is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, and to aid in biomedical research. They are also a leader in development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women.


  • Responsible for the support of launched/approved products and operations processes and the creation and transfer of manufacturing processes from R&D to Manufacturing and site to site transfers of on-market products.
  • Responsible for the development of LEAN processes by the removal of waste and continuous improvement of existing process.
  • Responsible for the development of new processes, transfer to manufacturing and continuous improvement of existing processes.
  • Provide process support to Manufacturing and other Operations Groups.
  • Responsible for Pilot & Development Manufacturing activities, Scale-Up of production processes as the production demand dictates.
  • Provides the support needed to complete Process Validation activities and training of manufacturing staff during the validation cycle.
  • Directs Subordinates to complete assignments using established guidelines, procedures and policies. Monitors daily operations of the Process Transfer Department.


  • Ensures team actions and deliverables are completed to the required due dates and project timelines.
  • Works collaboratively to problem solve with other departments.
  • Performs document review and approvals for the department.
  • Operates effective performance management of the Process Transfer team setting appropriate and business aligned goals, reviewing against expectations.
  • Provides guidance and development opportunities for team members.
  • Develops validation strategies for projects and agrees with the responsible member of Quality Engineering.
  • Contributes to department budget creation and ensures that department expenditure is within or below expectations.
  • Assigns and determines the team workload and priorities.
  • Oversees the development inventory locations and development production activities
  • Produces notebook, development, pilot and production materials
  • Oversees ERP real time transactions.
  • Reviews and independently generates notebook studies, technical reports, development and manufacturing documents.
  • Oversees and executes process validation of new and existing manufacturing processes
  • Represents Process Transfer on one or more core teams.
  • Provides the main point of contact and participates on behalf of Process Transfer in FDA and ISO lab audits.
  • Assists with troubleshooting experimentation required for projects.
  • Troubleshoots complex manufacturing process problems.
  • Oversees the development of manufacturing processes for transfer to Manufacturing.
  • Trains Manufacturing Operators on newly developed procedures.
  • Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs.
  • Reports periodically to management on project progress and status.
  • Provides technical support to Operations groups
  • Responsible for the Engagement plan and execution for the Process Transfer team.
  • Drive Value Improvement Project initiative for the team.


  • Typically requires BA or BS and experience desired
  • Working knowledge of experimental design.
  • Advanced knowledge of current GMPs.
  • Blood Borne Pathogen training.
  • Interpersonal skills
  • Technical skills
  • Work under own initiative and uses own judgment
  • Works collaboratively
  • Builds working relationships
  • Problem Solving
  • Proficiency with MS Word and Excel.
  • Strong math skills.
  • Applied knowledge of Technical writing.
  • Experience with presentation skills.

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