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Job Description:

In the R& D Microbiology Centre of Excellence (Beerse, Antwerp, Belgium) there is currently a full-time opening for a microbiology analyst conducting microbial method development, GMP method qualification/validation, and release and stability testing in support of the clinical development portfolio.

R& D Microbiology Analyst

Your Function

• Execute method development and GMP method qualification/validation for a diverse range of microbial assays, such as bioburden testing, bacterial endotoxin testing, sterility testing, etc.;
• Perform release and stability testing on clinical products;
• Coordinate and execute Low Endotoxin Recovery (LER) studies;
• Coordinate and execute Microbial Challenge studies to determine hold time of sterile preparations;
• Author, review and approve development reports, qualification/validation reports and test method descriptions;
• Coordinate laboratory investigations;
• Ensure compliance with regulatory requirements, GMP and safety.

Your Profile

• Bachelor’s degree in Biomedical Laboratory Technology, or equivalent through experience;
• Good knowledge of and experience with aseptic and microbiological techniques;
• Experience with GMP;
• Meet high quality standards when executing experiments;
• Efficient, flexible and dynamic. Capable of dealing with changes in the planning;
• Team player yet able to organize and execute the work independently;
• Demonstrate sense of urgency;
• Good knowledge of English, both spoken and written.

You will be welcomed in a diverse and coherent team, and will receive proper training by experienced analysts in order to fulfill your role.

Departmental responsibilities

As part of Johnson & Johnson Innovative Medicine, R& D - Discovery, Product Development, and Supply (DPDS) – Analytical Development (AD), the Microbiology CoE has the following responsibilities:

• Providing global support for all microbiology-related aspects during clinical development (R& D) and life cycle management (commercial) of the J& J Innovative Medicine product portfolio (Biotherapeutics and Synthetics).
• 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.

Validation and implementation of innovative microbial technologies for established and new product platforms.