CLS Services

Gepubliceerd: 24 days ago

Assistant/Associate Scientist Stability

Leiden
Gepubliceerd: 24 days ago
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for an Assistant/Associate Scientist Stability.

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
As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, Stability, NPI & New technology group is responsible for the oversight of stability and release programs of commercial biological products such as Darzalex, Remicade, Stelara and products in process validation for commercialization such as CNTO4424, GPRC5D, CD3 etc.
The services provided by this department also include technical transfer of the NPI’s, data management, release testing of raw materials, biological drug substances and drug products.

Job description
Do you have some Project Management experience in the pharmaceutical industry and do you have affinity with laboratory? We are looking for an experienced technician who likes to work in a new team!

In this role you who will be responsible for the coordination of the release of raw materials, drug substance and drug products from internal and external stakeholders (CMOs). You coordinate the stability testing of JSC large molecule products according local procedures and data requests provided by various stakeholders (RA; Health Authority; DPDS etc). You are the subject matter expert on release and stability processes and has a leading role during the GMP inspections. Additionally, you have the accountability to plan, organize, prioritize and execute the Data Requests based on the stakeholder requests. Finally, you have affinity and motivation to lean the process continuously and to apply Business Excellence and Faster Forward tools.

Who we're looking for
For this role we are looking for candidates with a BSc. or MSc. background and at least 3 years of work experience in a pharmaceutical environment. Some experience in Project Management is mandatory. You have thorough knowledge in the use of lab systems & lab environment, particularly around data integrity and data management (eg. eLIMS). Because of the nature of the job English speaking & writing is required (external client contact being a key part of the role).
We#39;re looking for someone with either lab background and coordination affinity or a coordinator with lab affinity. As this is a relatively new team/department as a result of an internal reorganisation you need to have a flexible and proactive personality and you are able to define your own work.

Additional vacancy information
Reference: A2000054
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
WO/MSc.
Terms: Project for at least one year. Full time preferred, 32 hours discussable.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555

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Fulltime / parttime

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