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Team Leader GMP
Eingestellt von Experis AG
Projektbeschreibung
Team Leader GMP
Experis IT Switzerland is currently on the search for an experienced GMP Team Leader to join one of their clients, a global and well renowned pharmaceutical company. For this long term temporary assignment we are in search of an English and German speaking candidate who is immediately available and ready to work in Bern.
Are you a highly GMP Team Leader with proven USP and DSP experience looking for a new and exciting challenge? Then, apply now!
YOUR RESPONSIBILITIES:
You as a GMP Team Leader will be responsible for defining objectives and activities related to GMP production within the process development department:
- Timely delivery of product or intermediate product of the correct quality and quantity to meet project demands
- Supervision of the team and responsible for the development of staff, performance of appraisals
- Define team objectives, translate them into activities and take responsibity for the overall results of those activities
- Supports technology transfer within the Development organization and cross functional with other parties
- Assures that data from CTM manufacturing is prepared, analyzed, interpreted and retained accurately
- Write, review and approve Study Plansrepresent own expertise field within and outside of the organization
- Participates, as the USP/DSP production Subject Matter Expert, in regulatory inspections and is experienced with the required GMP and regulatory guidelines
- Maintain and continuously improve cGMP compliance within USP/DSP area
YOUR PROFILE:
- Minimum 5 years of relevant experience in CMC development of Biologic
- Knowledge and experience of cGMP manufacturing of CTM and/or commercial drug substance
- SME experience in USP/DSP area ("Anaerobic" Fermentation, Centrifugation and Ultrafiltration) including pilot scale and technology transfer
- Several years' experience with in a same position
- Knowledge and interpretation/implementation ability of cGMP and current Regulatory Compliance Guidelines
LOCATION: Bern, Switzerland
START DATE: 20.06.2017
DURATION: 11 months
Don't hesitate and send us your CV today through the link in the advert. In case of any questions please contact Julie Mackerer.Please only apply if you have an EU or Swiss nationality.
Experis IT is Europe's leading IT&T recruitment agency. Take a look at our homepage for other interesting opportunities or call us.
Experis IT Switzerland is currently on the search for an experienced GMP Team Leader to join one of their clients, a global and well renowned pharmaceutical company. For this long term temporary assignment we are in search of an English and German speaking candidate who is immediately available and ready to work in Bern.
Are you a highly GMP Team Leader with proven USP and DSP experience looking for a new and exciting challenge? Then, apply now!
YOUR RESPONSIBILITIES:
You as a GMP Team Leader will be responsible for defining objectives and activities related to GMP production within the process development department:
- Timely delivery of product or intermediate product of the correct quality and quantity to meet project demands
- Supervision of the team and responsible for the development of staff, performance of appraisals
- Define team objectives, translate them into activities and take responsibity for the overall results of those activities
- Supports technology transfer within the Development organization and cross functional with other parties
- Assures that data from CTM manufacturing is prepared, analyzed, interpreted and retained accurately
- Write, review and approve Study Plansrepresent own expertise field within and outside of the organization
- Participates, as the USP/DSP production Subject Matter Expert, in regulatory inspections and is experienced with the required GMP and regulatory guidelines
- Maintain and continuously improve cGMP compliance within USP/DSP area
YOUR PROFILE:
- Minimum 5 years of relevant experience in CMC development of Biologic
- Knowledge and experience of cGMP manufacturing of CTM and/or commercial drug substance
- SME experience in USP/DSP area ("Anaerobic" Fermentation, Centrifugation and Ultrafiltration) including pilot scale and technology transfer
- Several years' experience with in a same position
- Knowledge and interpretation/implementation ability of cGMP and current Regulatory Compliance Guidelines
LOCATION: Bern, Switzerland
START DATE: 20.06.2017
DURATION: 11 months
Don't hesitate and send us your CV today through the link in the advert. In case of any questions please contact Julie Mackerer.Please only apply if you have an EU or Swiss nationality.
Experis IT is Europe's leading IT&T recruitment agency. Take a look at our homepage for other interesting opportunities or call us.
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