Scientist/ Microbiologist

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.

About the role

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

Responsibilities

• Independently perform microbiological and analytical testing activities in accordance with approved procedures, methods, specifications, and cGMP requirements.
• Conduct microbial limits testing of raw materials, in-process materials, finished products, stability samples, and other GMP samples.
• Perform environmental monitoring sampling and testing of manufacturing areas, controlled environments, and supporting locations.
• Conduct utility sampling and testing, including water sampling activities, as applicable.
• Perform cleaning verification sampling and testing using approved analytical methods, instrumentation, and applicable laboratory systems.
• Prepare media, reagents, standards, solutions, and other laboratory materials as required.
• Work on problems of moderate scope where analysis requires evaluation of identifiable factors and exercise of scientific judgment within generally defined practices.
• Independently complete assigned testing activities, projects, and documentation to support agreed timelines, milestones, and deliverables.
• Interpret, evaluate, communicate, and accurately document laboratory results.
• Review laboratory data for accuracy, completeness, compliance, and data integrity as a qualified and effective data reviewer.
• Maintain laboratory notebooks, worksheets, electronic records, files, and supporting documentation in compliance with current GMPs, SOPs, and data integrity requirements.
• Conduct and document laboratory investigations, deviations, and corrective/preventive actions as assigned.
• Support or author test methods, sampling procedures, protocols, reports, SOPs, specifications, summary reports, and certificates, as applicable.
• Operate, maintain, and troubleshoot laboratory instrumentation and equipment following approved procedures.
• Support Quality Systems and laboratory systems, including change controls, investigations, deviations, and other compliance-related activities as applicable.
• Communicate testing status, project updates, laboratory issues, and investigation progress to management and cross-functional teams.
• Collaborate with Quality Assurance, Manufacturing, Analytical Services, Microbiology, and other groups as needed to ensure project and testing requirements are met.
• Provide training, instruction, and guidance to junior-level scientists, microbiologists, analysts, or laboratory personnel as assigned.
• Support laboratory housekeeping, inventory management, equipment maintenance, and supply ordering activities.
• Monitor assigned work schedules and maintain target dates for completion.
• Comply with all applicable quality, safety, environmental, cGMP, and company procedures.
• Perform other technical and administrative duties as assigned.

Requirements

• 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.

Qualifications

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

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

• Regularly sit, stand, walk, bend, reach, and perform repetitive hand movements while conducting laboratory activities.
• Occasionally lift and carry up to 15 pounds.
• Access laboratory, manufacturing, warehouse, utility, and office areas as required.
• Perform sampling and testing activities, including aseptic techniques where applicable, in controlled environments.
• 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.
• Sufficient manual dexterity to operate laboratory equipment, perform microbiological plating and sampling activities, prepare solutions and reagents, and accurately document test results.
• Ability to communicate effectively in both written and verbal formats and interpret written procedures, specifications, and instructions.

Work Environment

• Wear safety glasses and all other required PPE in designated laboratory and manufacturing areas.
• Follow all site safety, quality, environmental, and cGMP requirements.
• Be fit-tested, trained, and capable of wearing respiratory protection as required by OSHA regulations.
• Be trained in site hazardous material handling procedures and chemical hygiene practices.
• Use approved fall prevention devices when performing elevated sampling activities.
• Wear required safety footwear for up to 8–12 hours per day, depending on shift duration and assigned activities.
• Work within laboratory environments as well as 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.

Pay

Salary range is $70,000 to $80,000, depending on experience.

Benefits

• 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.