Stability Scientist

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. 

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What will your job be

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 

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

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

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.

More information

Esther Moerdijk
0182 590 215
Jurjen Wilschut
0182 590 212
Ref.nr: 6490

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