Scientist/ Microbiologist

Ardena • Franklin Township, NJ

11d • $70,000 - $80,000 • Onsite

About The Position

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.

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.
• 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.
• 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.

Nice To Haves

• Bachelor's or Master's degree in Microbiology, Chemistry, Analytical Chemistry, Biology, Biochemistry, or related scientific discipline.
• Experience with LIMS, ELN, CDS/CDMS, or other laboratory data systems preferred.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree