The companyOur client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands. This company is committed to developing first-in-class or best-in-class vaccines for some of the world's most life-threatening infectious diseases. They have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden they have a workforce of 700 scientists and support staff, 45% of their employees have a nationality other than Dutch with over 20 nationalities represented. They 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.
In their organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central point. In order to strengthen our team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company.
The Quality Control Development (QCD) labs group is part of the Analytical Development (AD) Department of the Vaccines Process & and Analytical Development (VPAD) 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 virus and antibody products for use in clinical trials and the analytical support of the pilot plant activities.
The QCD Labs group focuses on supporting production and laboratory activities with:
- Release and Stability team is responsible for all internal release and stability testing (R&S team)
- Inspection, release and change management of incoming production raw materials and laboratory chemicals (Raw-Materials Team)
- Sample and Material receipt, handling, storage and forwarding (Sample Management Team)
- Cell Culture services where cells are maintained used for assays and production cell line quality is supported (Cell Culture Team)
- Microbiology group mainly responsible for maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs (Microbiology Team)
- Coordination of Release and Stability testing and Outsourcing Coordination (Coordination Team)
Role descriptionThey are looking for a suitable candidate to reinforce their release and stability team as team lead with 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. You have well developed people skills and are an experienced people manager. You are able to work in an ever changing environment with short timelines. Continuous improvement is something you believe in and enforce. You are able to work closely with your fellow team lead and together bring the team to the next level.
Responsibilities- Accountable for the personnel on his/her 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
- 5-10 years of experience in a pharmaceutical environment
- 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
- Flexible and accurate
- Well-developed interpersonal skills and able to build strong relationships
- Highly proficient in spoken and written English. Dutch is considered a strong plus.
Other informationFor this position they are looking for someone who is available for a longer period of time.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.