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Leiderdorp is home to the European R&D organization of Astellas focusing on the development of medicines in the areas of Pain, Urology and Diabetes/Metabolic diseases. An R&D investment budget of 15-20% is evidence of the company's commitment to improving the health of people worldwide through the provision of innovative and reliable products. Leiderdorp is also the head office for Astellas Pharma Netherlands (the Dutch affiliate) and for Astellas Pharma International. Astellas Pharma International is present in Central and Eastern Europe, including the Baltic States and the Balkan countries, as well as the Near & Middle East, Africa and some other selected countries. Voor Astellas we are currently looking for a:
Laboratory Head
The position of Laboratory Head is located in the Control & Investigation Section of our Pharmaceutical Development Department. The C&I section is responsible for:
- Analysis of clinical trial material, comparators and placebo for release and stability
- Development and implementation of analytical methods for clinical trial material
- Drug characterization studies and formulation support
- Support EU and Global Change control for commercial products on request
The C&I section strongly interacts with interdepartmental sections and their counterparts in Japan and US. The current staff consists of 25 people, of which 11 (senior) analysts, 3 (senior) scientists and a section head. The new function Head Laboratory will have full managerial responsibility for the operational tasks including managing the analytical personnel involved: planning and execution of analytical tasks, compliance, sample management, maintenance and calibration of facility, equipment and glassware. Some of our frequently used equipment are (U)HPLC's, dissolution, DVS, TGA/DSC. NIR and LC/MS will be introduced this year. He or she will work closely with the section head, the analytical study managers and with colleagues in and outside the section.
Core Tasks
· Give operational input on pharmaceutical development strategy
· Supervise own staff to execute studies to meet their timeline and required quality.
· Identify potential problems or delays in studies, seek solutions and take the action necessary to correct the problem.
· Identify and implement new procedures to maximize the throughput but by maintaining the optimum quality standards.
· Carry out the full managerial responsibility in his/her group, including:
o continuous performance management (target setting, progress & quality review, intermediate & annual appraisal)
o coaching & development of own staff
o review & approval actual versus planned capacity (time writing)
o formal & informal communications including regular group meetings to exchange experiences, improve ways of working
o monitoring of client (internal, external) satisfaction
o budget adherence
· Contribute to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of Astellas business processes.
· Ensure cGMP compliance for all activities.
Profile
· A completed study at the HLO or university in chemistry, biochemistry or environmental chemistry.
· Relevant experience in pharmaceutical industry
· Demonstrable line management experience
· Good communication skills especially in the Dutch language and preferably also in English
· Adequate knowledge to work with information technology systems (eg. Windows and MsOffice)
· Scientifically interested
· Empathy
· Hands on and enterprising
· Dares to take decisions
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