Introductie

Janssen is an innovative pharmaceutical company, part of Johnson & Johnson, with company sites worldwide. Janssen has over 5000 employees in Belgium (working at sites in Beerse, Geel, Olen, Merksem, Diegem and La Louvière) and over 2000 employees in The Netherlands (working at sites in Leiden).

Het bedrijf / The company

Collaboration Beerse and Leiden

There is close collaboration between the Janssen sites. For example, the Microbiology Expert team of Discovery, Product Development, and Supply (DPDS) at Beerse is supporting Analytical Development (AD) within Janssen Vaccines Leiden. AD at Janssen Vaccines Leiden is responsible for developing methods that are required for analysis of viral vaccines for human use (analysis includes testing for identity, quantity, potency, purity, and viral and microbial contamination). The Microbiology Expert team of DPDS has the following responsibilities:

Providing global support for all microbiology-related aspects during clinical development (R&D) and life cycle management (commercial)
Coordinating microbial method development, validation/qualification and transfer activities with internal and external microbiology laboratories
Microbial specification setting and control strategy
Microbial risk assessments and investigation support
Supporting regulatory inquiries in the field of microbiology
Implementing innovative microbial technologies for established and new product platforms

In 2021 and as long COVID19-travelling restrictions apply, this individual will work remotely. Working at sites will be incidentally and if it occurs, it will be mainly in Beerse and exceptionally in Leiden.

Extra info

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
2105907446W

De functie / The role

Job description

To strengthen the team responsible for analysis of viral and microbial contaminants for Janssen’s COVID-vaccine candidates, we are looking for a Scientist who has experience with viral and microbial safety, enjoys working in a multidisciplinary team, and has a strong quality mind-set to manage GMP documentation and transfer of methods to QC labs.



This individual will be responsible for managing worldwide safety assurance of COVID-vaccine candidates with regard to viral and microbial contamination. This includes oversight of high quality and compliant documentation required for assessing and preventing viral and microbial safety risks. Furthermore, this individual has oversight of in-process control and release methods to be conducted at GMP level in-house, at contract laboratories and at contract manufacturers.


Transfer Scientist Academy

Together with 10 other transfer scientists (stationed at AD in Leiden) you will follow diverse soft skill trainings and you will have monthly individual coach sessions with an experienced career coach. This is called the Transfer Scientist Academy of Procam, one of the partners of Janssen. Procam will also conduct a part of this recruitment process (see below: Recruitment process).

Het profiel / Your profile

Qualifications
Qualifications

PhD-degree in a relevant field e.g. Bioscience Engineering, Biology, Biomedical Sciences or similar with a strong expertise in the field of microbiology
Experience with method development and validation (e.g., for cell-based and molecular methods, Bioburden Sterility, and Endotoxin testing)
Experience with GMP and/or other quality management systems
Experience within pharmaceutical industry is preferred
Excellent communication skills in English (written and oral)


Competencies

Strong scientific basis
Good project management skills and able to handle multiple projects simultaneously
Effective communication with varied levels of the organization
Strong sense of responsibility
Eye for flawless and accurate documentation

Reactie / Reaction

Recruitment process

Recruitment and selection for the Janssen COVID-19 Method Transfer Scientists program is partly outsourced to Procam. You can apply online for this specific position in combination with the training program, for which a resume and motivation letter are required. Please describe which techniques you have experience with. The further process will be:



Screening of resume and motivation letter. If additional information is needed a short interview by phone may be required.
Assessment day by Procam (online Teams meeting), consisting of capability tests, a personality questionnaire, an interview with a Procam assessment psychologist and an interview with a Career coach. As a result of this assessment day, a personal profile will be drawn up.
Online interview(s) with Janssen managers from Leiden and Beerse.

Gegevens

Janssen
Johnson & Johnson
Leiden

Geplaatst op FMF: 11 maart 2021

Branche: Farma & Biotech, Medical
Functie: R&D
Opleidingsniveau: PhD
Werkervaring: 2-5 jaar, 5-10 jaar, > 10 jaar