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Method validation and regulatory filing specialist

2019-01-11 CLS Services | Leiden | WO / MBA | Fulltime | Sluit 2019-03-12

Do you have a Ph.D. in Life Sciences and are you an expert on method validation in pharmaceutical industry? We have a great opportunity for you! As a method validation and regulatory filing specialist, you will have the following responsibilities: - Direct the implementation of template ...

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 Method validation and regulatory filing specialist.

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.



Job description
Do you have a Ph.D. in Life Sciences and are you an expert on method validation in pharmaceutical industry? We have a great opportunity for you!

As a method validation and regulatory filing specialist, you will have the following responsibilities:

  • Direct the implementation of template validation plans and reports;
  • Ensure that all necessary procedures are followed and compliance with local and country guidelines and regulations for successful method validations;
  • May act as the senior author in the preparation of presentations, documents for regulatory filing, patents, scientific publications and journals;
  • Lead the proper documentation of method validations;
  • Review and monitor data management process to ensure that records are properly stored;
  • Lead execution of scientific endeavours and advance scientific projects based on results;
  • Use emerging developments in relevant scientific fields to generate new research ideas and initiatives;
  • Influence internal collaboration for multiyear projects across multiple disciplines.


Who we're looking for
The ideal candidate has a Ph.D. in Life Sciences complemented with postdoctoral experience and 6-12 years of business experience, or 3-5 years of business experience performing progressively advanced duties at a Senior Scientist level.
You are an expert in method validation in one or more of the following techniques: cell-based assays, ELISA or other quantitative binding assays and/ or qPCR. Furthermore, you have excellent interpersonal skills and you are fluent in English.
Are you the method validation expert we are looking for?

Additional vacancy information
Reference: A1900004
Contract: Temporary contract with CLS Services
Education: PhD.
Terms: Project for at least 1 year, 32 hours discussable.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555



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