Process Project Manager Pharmaceutical Technology and Support Job - Netherlands
- 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.
- 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),
- 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.
- 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
- 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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