CheckMark Labrecruitment

Gepubliceerd: ongeveer 1 maand geleden

Stability Scientist

Gepubliceerd: ongeveer 1 maand geleden
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Waar ga je aan de slag - Where will you work

A global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Wat ga je doen - What will your job be

Do you want to manage stability studies within a big pharmaceutical company? As a Stability Scientist it is your reponsibility to coordinate stability studies of biopharmaceuticals. You oversee study plans, timelines, regulatory (GMP, EP, ICH) compliance and results to ensure product quality and safety. 

You will help manage stability studies  For this purpose you coordinate (outsourced) analyses, data trending, quality documentation and performance. Your responsibilities will include:

  • Ensuring stability studies are conducted in full compliance with GMP and in accordance with Pharmaceutical Guidelines (e.g. USP, EU, EP, GMP)
  • Reviewing internal and external test results/raw data (on paper and in LIMS). Furthemore you ensure timely sample pulling and validation/qualifiaction of stability methods
  • Performing stability data interpretation and statistical trending for products under stability program to assign shelf-life periods
  • Working closely with contract research organisations (CRO's) in outsourcing of stability studies to third parties 
  • Supporting preparation / updated of new procedures, test instructions, equipment instructions, if required 

Wat vragen wij - What are we looking for

For the position of Stability Scientist we are looking for a communicative, motivated and independent candidate.

  • A Msc or PhD degree in Bio- or Pharmaceutical Sciences 
  • Minimal 2 years of experience in industrial/commercial environment working to GMP standards
  • Experience with lab activities in a GMP environment, where documentation plays a major role, is considered a great advantage, though this is not a hands-on lab role
  • Experience with methods qualification/validation and knowledge of statistical analyses and data trending
  • Preferably experience in stability study design, management and reporting of stability data for IND/IMPD/NDA
  • Fluent in English. Dutch is considered a plus

Wat hebben we te bieden - What do we offer
  • A one year secondment via CheckMark Labrecruitment
  • Salaryindication 3500 - 4300,- gross a month based on fulltime
  • 32 - 40 hours
  • Interviews will take place after the 12th of january 2020

Wil je meer weten - More information

Neem voor meer informatie contact op met Esther Moerdijk 0182 590 215
Vacaturenummer: 6490

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