Scientist​/ Microbiologist

About Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

Ardena is hiring a Scientist/ Microbiologist to join the Analytical Services team at our Somerset site. This role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment.

As a Scientist/ Microbiologist at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within the Analytical Services. You will work in a regulated pharmaceutical environment, ensuring that all work meets GMP, GxP, and applicable ISO standards.

You will collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Project Management, Production, and other departments across Ardena’s European and US sites.

The Scientist/Microbiologist is responsible for independently performing microbiological and analytical laboratory testing in support of pharmaceutical manufacturing and quality control activities. This position supports the timely testing and release of raw materials, in-process materials, finished products, environmental monitoring samples, utility samples, cleaning verification samples, and other GMP-related samples.

This role performs microbial limits testing, environmental monitoring, utility sampling and testing, cleaning verification testing, data review, laboratory investigations, and technical documentation in accordance with approved procedures, cGMP requirements, compendial expectations, data integrity standards, and company policies. The Scientist/Microbiologist is expected to exercise scientific judgment within established procedures, communicate testing status and results, support investigations and deviations, and contribute to laboratory compliance, efficiency, and continuous improvement.

• Independently performs microbiological and analytical testing activities in accordance with approved procedures, methods, specifications, and cGMP requirements.
• Conducts microbial limits testing of raw materials, in-process materials, finished products, stability samples, and other GMP samples.
• Performs environmental monitoring sampling and testing of manufacturing areas, controlled environments, and supporting locations.
• Conducts utility sampling and testing, including water sampling activities, as applicable.
• Performs cleaning verification sampling and testing using approved analytical methods, instrumentation, and applicable laboratory systems.
• Prepares media, reagents, standards, solutions, and other laboratory materials as required.
• Works on problems of moderate scope where analysis requires evaluation of identifiable factors and exercise of scientific judgment within generally defined practices.
• Independently completes assigned testing activities, projects, and documentation to support agreed timelines, milestones, and deliverables.
• Interprets, evaluates, and accurately documents laboratory results.
• Reviews laboratory data for accuracy, completeness, compliance, and data integrity as a qualified and effective data reviewer.
• Maintains laboratory notebooks, worksheets, electronic records, files, and supporting documentation in compliance with current GMPs, SOPs, and data integrity requirements.
• Conducts and documents laboratory investigations, deviations, and…