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Sr Scientist / Consultant Regulatory Filing in Leiden



Introductie

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.

De functie / The role

16-32 hours, 3 months, possible extention, home based is also possible.

This individual will be responsible for the extraneous agents safety of products developed by Janssen Vaccines Leiden. In particular, this individual will be responsible for translating Janssen Vaccines Leiden"s extraneous agents safety strategy into company position papers and/or briefing books for health authority"s scientific advice.

Demonstrating flawless documentation, effective communication with varied levels of the organization, a strong sense of responsibility and a passion for quality are key competences for this position.

Het profiel / Your profile

Skills & Experience sought:

Knowledge of viral safety(e.g., in vitro and in vivo adventitious virus testing, human/bovine/porcine virus testing)
Regulatory Affairs specialization (min 8 years)
Biopharmaceutical manufacturing (preferred)
Must have excellent writing skills
Enjoys working in a multidisciplinary team

Minimum Qualifications:

PhD-degree with publications and excellent writing skills
Minimal 8 years of experience with regulatory filing

Reactie / Reaction

More information about the Sr Scientist / Consultant Regulatory Filing? Please contact Leonie Koomen at Leonie@heraklespharma.nl or 06-10518323


Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


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Gegevens

Werkgever:
Janssen vaccins
Vacaturesteller:
Herakles pharma staffing
Standplaats:
Leiden

Geplaatst op FMF: 08 augustus 2019

Branche: Farma & Biotech
Functie: QA / regulatory, R&D
Opleidingsniveau: PhD
Werkervaring: 5-10 jaar, > 10 jaar