Sr. Scientist Validation / Regulatory affairs (Farma)

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Match criteria
Gewenst aantal uren
  • Full-time
  • ,
  • 32 uur
  • ,
  • 24 uur
  • Zuid-Holland
  • Tijdelijk
  • Euro 4000 - 4250
  • ,
  • Euro 5500 - 6000

Functie omschrijving

The Analytical Development department within Janssen Vaccines Leiden (one of the pharmaceutical companies of Johnson & Johnson) is responsible for developing methods that are required for analysis of vaccines for human use. Analysis includes testing for identity, quantity, potency, purity and contamination; in particular, extraneous agents safety. As Senior Scientist you are responsible for method validations and readiness for regulatory filing. Key Responsibilities include:

  • Operations Management
  • Directs the implementation of template validation plans and reports
  • Ensures that all necessary procedures are followed and compliance with local and country guidelines and regulations for successful method validations
  • Information Management and Communication
  • May act as the senior author in the preparation of presentations, documents for regulatory filing, patents, scientific publications and journals
  • Leads the proper documentation of method validations
  • Reviews and monitors data management process to ensure that records are properly stored
  • Program/Project Management
  • Leads execution of scientific endeavors and advances scientific projects based on results
  • Uses emerging developments in relevant scientific fields to generate new research ideas and initiatives
  • Influences internal collaboration for multi-year projects across multiple disciplines

Functie eisen

We are looking for a professional with the following background:

  • Ph.D. degree with post-doctoral experience and 6-12 years of business experience or 3-5 years of business experience performing progressively advanced duties at the Senior Scientist level, or the equivalent training/experience
  • Method validation expert
  • Experience with regulatory affairs
  • Experienced in one or more of the following techniques: cell-based assays, ELISA or other quantitative binding assays and/ or qPCR
  • Interpersonal skills - good command of speaking and writing of country languages and English, ability to communicate effectively with investigational site staff, team members and functional manager.


LabResource is the top tier supplier of Janssen Vaccines and Prevention BV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is dedicated to bringing meaningful innovation to global health.


In the our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen the team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.


Contract: 1 year via LabResource , realistic long term perspective
Salary: €4000 - €6000gross monthly
Hours: fulltime highly preferred
Region: Leiden


Regio Leiden

Publicatie datum



T Remijn
T: (020) 4069 750

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Werk telefoon: (020) 4069 750
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