Microbiology Expert – Small Molecules

Microbiology Expert – Small Molecules

PDMS Microbiology is a central service partner, providing global support in the field of microbiology for clinical Small Molecule and Large Molecule programs, as well as Lifecycle Management programs.

The department’s responsibilities include setting specifications for drug products, finished products, drug substances, excipients, packaging materials, and in-process controls; developing and implementing global method qualification/validation approaches; and owning global microbiological test methods and their transfers.

General Mission

As Microbiology Expert – Small Molecules, you will play a key role in coordinating and driving microbiology-related activities across global projects. You will combine your technical microbiological expertise and GMP knowledge with strong project management skills and scientific input in the development, qualification, and transfer of microbiological methods.

You will be responsible for:

• Leading and coordinating R&D and Lifecycle Management projects related to microbiology for Small Molecule products.
• Providing scientific input on microbiological method development, method qualification/validation, and specification setting for drug products, substances, and raw materials.
• Acting as project lead for global method transfer and harmonization activities across Janssen sites and external partners.
• Reviewing and approving development reports, qualification/validation reports, and microbiological test methods (sterility, microbial purity, ATP bioluminescence, bioburden, bacterial endotoxin, PET/AET, etc.).
• Coordinating, assessing, and following up on Change Controls (CCs) within the microbiology domain.
• Reviewing and approving microbiology-related specification documents in alignment with global standards.
• Ensuring compliance with all relevant GMP, regulatory, and J&J quality requirements.
• Contributing to the continuous improvement of microbiological strategies and global alignment within PDMS.

• PhD degree in Pharmaceutical Microbiology, Life Sciences, or related field
• Profound knowledge of pharmaceutical microbiology, including microbiological test methods, contamination control, and sterility assurance.
• Strong understanding of pharmaceutical regulations and GxP principles (FDA, EU, ICH).
• Proven experience in project management within a global or cross-functional environment, ideally in R&D or QC-related settings.
• Demonstrated ability to provide scientific and strategic input on microbiological method development and specification setting.
• Experience with method validation, transfer, and lifecycle management.
• Self-motivated, hands-on, and capable of managing multiple priorities efficiently.
• Excellent stakeholder management and communication skills; able to influence and align in a global matrix organization.
• Competency in professional and scientific English (spoken and written).
• Experience with Trackwise, Docspace, and other quality systems is an asset.
• Experience working in a GMP-regulated pharmaceutical environment is required.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
• Werk waar en wanneer je het beste presteert voor een ideale werk-privébalans.
• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.