Associate Scientist
il y a 15 heures
**Function**
- Non-Standard
**Sub function**
- Workday Associate B
**Category**
- Associate, Workday Associate B
**Location**
- Beerse / Belgium
**Date posted**
- May 21 2025
**Requisition number**
- R-014330
**Work pattern**
- Fully Onsite
Description
**Job Function**:
Non-Standard
** Job Sub Function**:
Workday Associate B
** Job Category**:
Non-Standard
** All Job Posting Locations**:
Beerse, Antwerp, Belgium
** 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.
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