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. 

Solliciteer direct Terug naar overzicht

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 6490

Solliciteer op Stability Scientist

Het wachtwoord moet minimaal 8 karakters lang zijn en minimaal 3 van de volgende bevatten: een hoofdletter, een kleine letter, een cijfer, een speciaal teken (!@#$%^&*()[]{}-_=+<>|)
De wachtwoorden zijn niet gelijk
Specificeer de job alert