Microbiology Expert – Small Molecules

Pauwels Consulting; Beerse; On-site; EUR 65,000 - 95,000; Full time

Job summary

Pauwels Consulting seeks a Microbiology Expert – Small Molecules to support clinical and lifecycle management programs in a GMP-regulated environment. You will coordinate global microbiology activities and provide scientific input on method development, qualification, validation and transfer.

Fluent in English with 3+ years in pharma, you will lead cross-site microbiology projects, review validation docs, and ensure compliance with GMP/GxP standards while partnering with external and internal

Qualifications

• Master's degree in Pharmaceutical Microbiology, Life Sciences, or a related field.
• 3+ years of experience in a GMP-regulated pharmaceutical environment.
• Knowledge of contamination control, sterility assurance, bioburden, and bacterial endotoxin.
• Experience with microbiological method validation, qualification, and transfer.
• Experience with Small Molecules and PET/AET, ATP bioluminescence, and microbial purity.
• Strong project management and stakeholder influence in a global matrix organization.
• Fluent in English.

Responsibilities

• Lead and coordinate microbiology-related R&D and Lifecycle Management projects for Small Molecule products.
• Provide scientific input on microbiological method development, qualification, validation, and specification setting.
• Act as project lead for global method transfer and harmonization activities across various sites and external partners.
• Review and approve development reports, validation documentation, and microbiological test methods including sterility, bioburden, and bacterial endotoxin.
• Coordinate and follow up on Change Controls and specification documents within the microbiology domain.
• Ensure compliance with all relevant GMP, GxP, and regulatory standards.

Skills

Microbiology

GMP compliance

Project management

Stakeholder influence

English proficiency

Education

Master's degree in Pharmaceutical Microbiology

Tools

Quality management systems

Document control software

Job description

Our client, a global pharmaceutical leader, is seeking a Microbiology Expert – Small Molecules to support clinical and lifecycle management programs. This role involves coordinating global microbiology activities and providing scientific expertise in method qualification and validation within an R&D environment.

Responsibilities

• Lead and coordinate microbiology-related R&D and Lifecycle Management projects for Small Molecule products.
• Provide scientific input on microbiological method development, qualification, validation, and specification setting.
• Act as project lead for global method transfer and harmonization activities across various sites and external partners.
• Review and approve development reports, validation documentation, and microbiological test methods including sterility, bioburden, and bacterial endotoxin.
• Coordinate and follow up on Change Controls and specification documents within the microbiology domain.
• Ensure compliance with all relevant GMP, GxP, and regulatory standards.

Requirements

• Master's degree in Pharmaceutical Microbiology, Life Sciences, or a related field.
• You have 3+ years of experience in a GMP-regulated pharmaceutical environment.
• You possess profound knowledge of pharmaceutical microbiology including contamination control, sterility assurance, bioburden, and bacterial endotoxin.
• You bring expertise in microbiological method validation, method qualification, and method transfer.
• You have experience with Small Molecules and techniques such as PET/AET, ATP bioluminescence, and microbial purity.
• You possess strong project management skills and the ability to influence stakeholders in a global matrix organization.
• You are fluent in English.

Nice to Haves

• Experience with quality management systems or document control software.
• Interest in contributing to R&D projects and continuous strategy improvement.