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Process Project Manager Pharmaceutical Technology and Support Job - Netherlands  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description


Description
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  • As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
  • This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Manufacturing Division AH strategy, Global AH Quality strategy as well as applicable regulatory requirements.
  • The position holder is responsible for and specialized in topics like product introduction and technology transfer, process improvement, process validation & analytical method transfer.
  • The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment.
  • The manufacturing sites that are supported by the person in this position can include those within the Animal Health Pharma region incl. third parties producing AH Pharma products.
  • The position holder will have to travel due to his/her activities in the Animal Health Small Molecules Region for 30% to 40% of his/her time.


Major Assignments:
  • Provide technical oversight, planning, coordination and support to manufacturing sites for projects related to:
    • R&D-to-Site product transfers
    • Site-to-Site product transfers
    •  API and starting material source changes
    • Process Robustness and Product maintenance (e.g. due to regulatory changes)
    • life cycle management, technical trouble shooting
    • Process Performance Qualification & Continue Process Verification
    • Overarching changes to products or materials.
  • Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (process & process validation robustness initiative) with target to improve efficacy (e.g. reducing off specs and cycle times, Right First time projects) at the manufacturing sites.
  • Support to establish consistent organizational process designs for all involved support processes in close collaboration with the program/project manager PTS e.g.:
    • Stage-gate-process (R&D-to-site) for new products (e.g. CMC-section review),
    • Transfers,
    •  Change control (APIs, excipients, packaging),
    •  Qualification/validation approaches.
  • Support of direct knowledge transfer between the manufacturing sites, support of development of global key technology platforms, technical expertise and Manufacturing Division technology network.
  • Facilitation of communication and interface for manufacturing sites to other global departments such as SCM, Regulatory Affairs, Pharma R&D, Strategic Procurement and CMO Organization.
  • Support or lead investigation teams established to solve major quality issues occurring with our AH pharma products.



Qualifications
  • Master or PhD degree in Science (Process technology, Pharmaceutical technology, Industrial Chemistry, Food technology,…) and at least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.
  •  Business Experience in projects as site to site and R&D to site transfers will be asset.
  •  Project management skills
  • Regulatory background incl. FDA and EMEA requirements or motivated to acquire this quickly.
  • Strong knowledge of GMP requirements or motivated to acquire this quickly.
  • Experienced in internal business processes and organization.
  • Travel requirement: willing to travel to the different AH Manufacturing Division production locations (40 % of the time)
  • Language requirements:
  •  English (fluent)
  • Dutch, German, French, Italian or Portuguese are an asset



Offer:
  • Our employees are the key to our company’s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
  •  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.


    
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