Release & Stability Analyst QC
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Release & Stability Analyst QC.
Due to expansion of work load we are looking for new employees.
Technical and job specific qualifications.
- Fully own end-to-end product testing process within Leiden QC with some support;
- 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;
- Act as subject matter expert on release and stability processes and has a leading role during the GMP inspections;
- Participate in meetings of the quality network organisation and partners 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.
Who we're looking for
We are looking for a candidate with Bachelor’s degree (or equivalent) in a relevant discipline with 2-4 years of related working experience. You have excellent verbal and written communication skills in both English and Dutch. Didactical skills to effectively transfer information in a training environment are essential.
Furthermore, you have advanced knowledge on lab systems and lab environment, data integrity and data management. Knowledge of statistical data analyses is nice to have.
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.
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. 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.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >3200|
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)
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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