The CMC (Project) Manager is responsible for coordination and management of Chemistry, Manufacturing and Control (CMC) activities of global and all regional products during drug development and the complete product life cycle. All activities are with a focus in the APEL territory (EU, ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Astellas Pharma Europe B.V.</STRONG>, we are searching for a CMC Project Manager.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
The CMC (Project) Manager is responsible for coordination and management of Chemistry, Manufacturing and Control (CMC) activities of global and all regional products during drug development and the complete product life cycle. All activities are with a focus in the APEL territory (EU, Switzerland, Norway, Iceland, Russia and CIS, Middle and Near East, Turkey and Africa) to assure timely and adequate new product development, product launch, product maintenance, product life-cycle management and product exit. The CMC Manager will be assigned as regional or global lead to development projects and/or commercial products (in-house and/or license-in).
- You will collaborate and align the CMC activities with other disciplines and functions;
- You manage regional and or global CMC activities;
- Set-up and monitor project budget;
- Lead the CMC team, product launch team and coordinate CMC activities;
- Represent Technology Division in alliance and partner programs;
- Coordinate non-routine CMC activities at contract manufacturing organizations;
- implement good project management practices within assigned projects.
Who we're looking for
You have a pharmaceutical or life sciences background (PhD.) and a minimum of 5 years experience in a similar posotion. You have knowledge of state-of-the art chemical, pharmaceutical, process, analytical and supply chain technologies. Also you have understanding of GMP and ICH guidelines and quality requirements for regulatory filings during development and commercial registration. You have preferably experience with co-licensing (advantage).
Your communication (in English) and management skills are well developed, to manage project activities and to support project activities. You are capable to act in an industrial environment with changing and different priorities.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least one year.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555
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