CLS Services

Gepubliceerd: 29 dagen geleden

Scientist Analytical Development-Quality

Gepubliceerd: 29 dagen geleden
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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 Vaccines & Prevention, we are searching for a Scientist Analytical Development-Quality.

Company profile
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Analytical development quality team is part of the Analytical Development Department of Janssen and focuses on the design, execution and evaluation of stability profiles and qualification of Reference Materials for novel vaccines. The group supports the clinical development stages of the vaccines platforms and generates data that is used in preparation for future commercialization.

Job description
Are you looking for a challenging new job where teamwork and strong organizational skills are important? If you like to work in a dynamic pharmaceutical environment where every day is different, let us know!

In your role as Scientist, you will be a key player in the management of the various reference material studies of the novel vaccines during the clinical development.
You will work in a multidisciplinary environment and have a focus on preparation of RM qualification protocols, RM qualification reports, Certificate of analysis, trending and monitoring of RM.
Additionally, you have a focus on review and approval of various scientific protocols, reports, documentation for IND/CTA filing and provide support during scientific investigations. As a Scientist, you will act as a support to Head of QC during audits, inspections, assessment of quality of suppliers, data decisions on products tested within QC, lead quality investigations (Deviations, OOS, CAPAs).
Since you are providing support to various CMC projects that are carried out in teams comprising members from different departments, teamwork and flexibility are two very important characteristics.

Who we're looking for
We are looking for a candidate with a MSc. or PhD. degree in Biochemistry, Pharmacy, or equivalent life sciences degree and at least 2-3 years pharmaceutical industry experience working under GMP standards. You have experience with reference Material qualification/bridging/management and analytical methods qualification and validation. Additionally, you have knowledge of statistical analyses and data trending.
As a person you are independent, flexible, motivated and enjoys working in a team. Because the job is not lab but #39;paper based#39;, you have excellent organizational skills, a good eye for detail and strong communication skills. You can adapt easily to ad-hoc changes in a dynamic environment with changing priorities.

Additional vacancy information
Reference: A2000010
Contract: Temporary contract with CLS Services
Education: WO/MSc.
Terms: Contract for at least one year. Full time preferred, 32 hours discussable.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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