Microbiology Expert – Small Molecules

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.