Scientist/ Microbiologist

Ardena; Franklin Township (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

Ardena in Somerset, NJ, is seeking a Scientist/ Microbiologist to join the Analytical Services team. You will perform microbiological and analytical testing in a GMP-regulated setting, ensuring data integrity and compliance with cGMP and ISO standards.

You will collaborate with QA, Regulatory, and Production to support testing and release of materials. The role emphasizes microbial limits testing, environmental monitoring, and laboratory investigations, with responsibilities spanning method

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, Analytical Chemistry, or related scientific discipline with relevant pharma/biotech experience.
• Associate’s degree with 5+ years of related GMP microbiology or analytical lab experience.
• Experience with microbial limits testing, environmental monitoring, and GMP documentation preferred.

Responsibilities

• Perform microbiological and analytical testing in accordance with approved procedures and cGMP requirements.
• Conduct microbial limits testing of raw materials, in-process materials, and finished products.
• Perform environmental monitoring sampling in manufacturing environments and controlled areas.
• Prepare media, reagents, standards, and datasets; document results and deviations.
• Collaborate with QA, Regulatory Affairs, and Production to support timely testing and release.

Skills

Microbiological techniques

Data review

GxP compliance

Environmental monitoring

Laboratory documentation

Education

Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, Analytical Chemistry, or related scientific discipline

Associate’s degree in Microbiology, Biology, Chemistry, Biochemistry, Analytical Chemistry, or related scientific discipline

Tools

LIMS

ELN

CDS/CDMS

Job description

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.

Job Overview

Position: Scientist/ Microbiologist

Department: Analytical Services

Location: Somerset (US)

Ardena is hiring a Scientist/ Microbiologistto join the Analytical Servicesteam 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.

Summary Description

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.

Key Responsibilities

• 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, communicates, 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 corrective/preventive actions as assigned.
• Supports or authors test methods, sampling procedures, protocols, reports, SOPs, specifications, summary reports, and certificates, as applicable.
• Operates, maintains, and troubleshoots laboratory instrumentation and equipment following approved procedures.
• Supports Quality Systems and laboratory systems, including change controls, investigations, deviations, and other compliance-related activities as applicable.
• Communicates testing status, project updates, laboratory issues, and investigation progress to management and cross-functional teams.
• Collaborates with Quality Assurance, Manufacturing, Analytical Services, Microbiology, and other groups as needed to ensure project and testing requirements are met.
• Provides training, instruction, and guidance to junior-level scientists, microbiologists, analysts, or laboratory personnel as assigned.
• Supports laboratory housekeeping, inventory management, equipment maintenance, and supply ordering activities.
• Responsible for monitoring assigned work schedules and maintaining target dates for completion.
• Complies with all applicable quality, safety, environmental, cGMP, and company procedures.
• Performs other technical and administrative duties as assigned.

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, Analytical Chemistry, or related scientific discipline with at least 3 years of relevant pharmaceutical, biotechnology, contract laboratory, GMP microbiology, or analytical laboratory experience; or
• Associate’s degree in Microbiology, Biology, Chemistry, Biochemistry, Analytical Chemistry, or related scientific discipline with at least 5 years of relevant pharmaceutical, biotechnology, contract laboratory, GMP microbiology, or analytical laboratory experience.

Preferred Qualifications

• Bachelor’s or Master’s degree in Microbiology, Chemistry, Analytical Chemistry, Biology, Biochemistry, or related scientific discipline.
• Experience with microbial limits testing, environmental monitoring, utility sampling/testing, cleaning verification testing, GMP documentation, laboratory investigations, and data review.

Knowledge/Skills

• Working knowledge and application of scientific principles, microbiological techniques, analytical techniques, and compendial requirements.
• Working knowledge of cleaning verification principles, sample handling, analytical testing requirements, and GMP documentation expectations.
• Strong knowledge of cGMP requirements, data integrity principles, and laboratory documentation practices.
• Strong background in microbial limits testing, environmental monitoring, utility sampling/testing, and cleaning verification testing.
• Ability to independently execute approved laboratory methods, procedures, and specifications.
• Ability to interpret, evaluate, and communicate laboratory data and testing results.
• Ability to serve as a qualified and effective data reviewer.
• Experience supporting laboratory investigations, deviations, corrective actions, and quality system activities.
• Ability to author or review laboratory procedures, test methods, protocols, reports, SOPs, specifications, summary reports, and certificates, as applicable.
• Proficiency with laboratory instrumentation, microbiological testing equipment, analytical equipment, and applicable electronic systems.
• Proficiency with Microsoft Office applications, including Teams, Word, Excel, and PowerPoint.
• Experience with LIMS, ELN, CDS/CDMS, or other laboratory data systems preferred.
• Ability to organize and prioritize multiple tasks, testing activities, and project deliverables.
• Ability to work effectively under pressure to meet deadlines.
• Strong written and verbal communication skills.
• Mathematical and reasoning ability.
• Ability to train, guide, or support junior laboratory personnel, as assigned.

Physical Requirements

• Individual may be required to regularly sit, stand, walk, bend, reach, and perform repetitive hand movements while conducting laboratory activities.
• May be required to occasionally lift and carry up to 15 pounds.
• Must be able to access laboratory, manufacturing, warehouse, utility, and office areas as required.
• Must be capable of