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Team Leader Release and Stability | cGMP | Leiden

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. Janssen Vaccines is committed to developing first-in-class or best-in-class vaccines for some of the world’s most life-threatening infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff, 45% of our employees has a nationality other than Dutch with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.

Role description

The Quality Control Development (QCD) labs group is part of the Analytical Development Department of the Vaccines Process & and Analytical Development sector. Overall, the QCD Labs unit consist of 6 sub-teams (Raw-Materials, Sample Management, Cell Culture, Microbiology, Coordination and Release and Stability) and is responsible for release and stability testing as well as the corresponding reporting of Janssen’s virus and antibody products for use in clinical trials and the analytical support of the pilot plant activities.

We are searching for a suitable candidate to reinforce our release and stability team as team lead with the main focus on support to our release and stability process of our vaccines. As team lead you are responsible for leading a team of 14 (sr.) technicians (assistant and associate scientists) in a GMP environment, of which 6-7 will report directly to you.

Responsibilities

• Accountable for the personnel on your team, their performance and development.
• First point of contact for all (sub) department specific related items.
• Acts as primary and/or subject matter expert for Quality during regulatory inspections, internal and external GMP -audits.
• Responsible for managing and coordinating the activities of the Release and Stability team.
• Ensure compliance with quality standards (GMP) and production schedules.
• Implement methods and procedures for inspection, testing and evaluation.
• Mentor, train and supervise team members.
• Evaluates performance and provides opportunities for growth.
• Communicates department objectives and metrics.

Requirements

• HBO level in a life science study
• At least 5 years of relevant experience in people management and/or process coordination
• At least 5 years of GMP experience
• Able to prioritize and make decisions
• Good organizational capabilities
• Well-developed interpersonal skills and able to build strong relationships

Other information

Please submit your application before the 28th of June.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.


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SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 17-06-2019
Country: The Netherlands
Region: Zuid-Holland
Employment: Permanent
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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