|
Astellas is an international pharmaceutical company employing over 15,000 people worldwide and with combined global sales of over 7 billion euro. The company’s European headquarters are based in London, with affiliates throughout Europe working in production, sales & marketing, and research & development. With over 3,500 employees, Europe is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Dermatology, Pain Management, Transplantation and Anti Infectives.
Leiderdorp (The Netherlands) is home to the European R&D organization focusing on the development of medicines in the areas of Pain, Urology and Diabetes/Metabolic diseases. An R&D investment budget of 15-20% of the company’s annual net earnings is evidence of the company’s commitment to improving the health of people worldwide through the provision of innovative and reliable products.
The Pharmaceutical Development Department (PDD) has own laboratories and manufacturing facilities for clinical trial materials and plays an important international coordinating role between the company’s manufacturing facilities and laboratories in Europe, Japan and USA. Besides that we make use of many specialized contractors in all parts of the world.
Associate Scientific Director
The job:
The CMC Project Management section of PDD is responsible for:
· Management of local CMC development teams
· Delivery of CMC contribution to drug development projects
· Delivery of CMC contribution to regulatory documentation
· International coordination of CMC aspects with Japanese and US counterparts
· Sourcing of CMC technology and materials
As a Project Manager you will coordinate all project team activities within the department.
Furthermore, you will be responsible for contracting out a significant part of the work to CRO’s.
Your personal qualifications:
· Pharmaceutical or analytical background at academic level with experience in an industrial R&D environment
· Knowledge of state-of-art pharmaceutical and analytical technologies and knowledge of formulation science will be appreciated
· Knowledge on EU GMP and ICH guidelines and experience with the preparation of the chemical and pharmaceutical parts of the registration files
· Good communication and project management skills to support the drug development team activities and maintain good relationships with contractors
· Capability to act in a global, multicultural, corporate environment with changing and different priorities
· Capability to operate within the quality requirements stated in the international GMP guidelines
· Good English communication skills, written and verbal.
We offer:
· A challenging and diversified job
· Good career opportunities
· Inspiring work climate
· Attractive remuneration.
Interested in other (lab)management positions? Click here! |
