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Release & Stability Scientist QC

Vacaturenummer: A2200047
Janssen Biologics B.V. - Leiden (Nederland)

For our client, Janssen Biologics B.V., we are looking for a Release & Stability Scientist QC.

Keywords

  • QC
  • Release and Stability
  • GMP
  • Lean/BE
  • Develop training material


Profile
The Release & Stability team leads and supports complex non-conformances investigations, initiates improvements to optimise the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC.
Currently the Release & Stability team consists of 14 people and due to expansion of work load they are looking for new employees.
Responsibilities:
  • Fully own end-to-end product testing process within Leiden QC independently;
  • Co-ordinate the release of raw materials drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines;
  • Co-ordinate the stability testing of JSC large molecule products according to local procedures and agreed timelines; 
  • Is a technical leader on biologics and/or vaccines release and stability testing processes and has a leading role during the GMP inspections; 
  • Participate in meetings of the quality network organisation and partner with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience;
  • Responsible to co-ordinate all data requests provided by various stakeholders (e.g. RA. Health Authority, DPDS) and has the accountability to plan, organise, prioritise and execute the data Requests based on the stakeholder requests; 
  • Responsible for reviewing the CPV plans and matrixes and update the QC release trend limits accordingly;
  • Provide input for the YBPR and APR requests;
  • Lead and drives continuous improvement projects;
  • Influence, develop and execute strategy for expertise area;
  • Train and mentor colleagues in expertise area;
  • Proactively share knowledge with team and other sites and functions to drive improvement and alignment;
  • Adhere to compliance best practices, EHSS regulations and lean principles;
  • Perform other work-related activities assigned by supervisor; 
  • Maintain compliance with all company policies and procedures.


Who we're looking for
The ideal candidate has a B.Sc. with 6-8 years of related working experience. You are an expert on lab systems, lab environment, data integrity, data management and statistical data analyses. You have experience with stakeholder management, project management and working according to GMP guidelines. Finally, you have Lean/BE experience. We are looking for someone with excellent communication skills who is able to develop training material.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Department
The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise. All test laboratories are supported by the Release & Stability team, which is integrated by product E2E QC owners who lead and co-ordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders (e.g. DPDS, PQM, VPAD, VCM, CMOs, EQ) and Leiden QC.

Additional vacancy information
Reference:A2200047
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
Employment terms:Salary: >4350
Days of leave: 36
See here our other employment terms for this vacancy
12 months contract in first place (extension possible, but not guaranteed)
40 hours, 32 hours also possible
job is onsite (currently 3 days remote but will change to 5 days in the future)
Publication date:29-3-2022
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.