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.
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
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.
Contract: 1 year via LabResource, realistic long term perspective
Salary: €4000 - €6000gross monthly
Hours: fulltime highly preferred
Senior position for an established scientist with a background in farma, valdiations and regulatory submissions
LabResource is het grootste laboratorium recruitment bureau in Nederland, gespecialiseerd in uitzenden, detacheren en werving & selectie binnen: Quality Assurance / kwaliteitszorg, research en development, product ontwikkeling, laboratoriumcoördinatie en management, procesvalidatie en optimalisatie.
Vacatures waar wij voor werven zijn onder andere: laborant, analist, Quality Assurance officer, laboratoria manager, R & D medewerker, applicatie specialist, organisch/ synthetisch technician, science / wetenschappelijk medewerker, technicians. Vakgebieden zijn onder andere: biochemie, life science, moleculair biologie, analytische chemie, petro chemie, microbiologie, biotechnologisch, scheikunde, organische chemie, synthese, voedingsmiddelen, farmacie, petrochemie, milieu chemie, scientific sales, geur en smaakstoffen, klinisch/medische chemie, medical devices, food & nutrician.
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