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/ 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.

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

o 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

o 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:

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

o 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 performing sampling and testing activities, including aseptic techniques where applicable, in controlled environments.

· Must be able to wear required personal protective equipment (PPE) for extended periods while performing laboratory and manufacturing support activities.

· Specific vision requirements include the ability to read written documents, laboratory instruments, computer screens, and test results.

· Requires sufficient manual dexterity to operate laboratory equipment, perform microbiological plating and sampling activities, prepare solutions and reagents, and accurately document test results.

· Must possess the ability to communicate effectively in both written and verbal formats and interpret written procedures, specifications, and instructions.

Work Environment/Safety Conditions:

· Must wear safety glasses and all other required PPE in designated laboratory and manufacturing areas.

· Must follow all site safety, quality, environmental, and cGMP requirements.

· Must be fit-tested, trained, and capable of wearing respiratory protection as required by OSHA regulations.

· Must be trained in site hazardous material handling procedures and chemical hygiene practices.

· Must use approved fall prevention devices when performing elevated sampling activities.

· Must be capable of wearing required safety footwear for up to 8–12 hours per day, depending on shift duration and assigned activities.

· Position requires routine work within laboratory environments as well as entry into manufacturing, warehouse, utility, and controlled environments.

· Environmental monitoring activities may require extended periods of standing and movement throughout manufacturing and support areas.

· Working conditions may include temperature- and humidity-controlled environments, controlled manufacturing areas, and classified areas requiring gowning procedures.

· Exposure to microbiological materials, cleaning agents, laboratory chemicals, and pharmaceutical materials may occur in accordance with established safety procedures and training.

· Noise levels are generally low to moderate within laboratory, office, and manufacturing areas.

Salary range is $70,000 to $80,000 DOE

What Ardena Offers

Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.

Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.

Benefits and perks at Ardena include:

• Competitive salary and tailored benefits package (adjusted per role and location)

• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)

• International and collaborative work environment across European and US sites

• Access to professional development and training programs

• Meaningful work on pharmaceutical development projects that advance patient health

• A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent

How to Apply

Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.