Scientist/ Microbiologist

About the role

The Scientist/ Microbiologist role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment. This position contributes to pharmaceutical development projects by performing scientific, technical, or operational activities within the Analytical Services.

Responsibilities

• Independently performs microbiological and analytical laboratory testing in support of pharmaceutical manufacturing and quality control activities.
• 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 established procedures.
• Interprets, evaluates, communicates, and accurately documents laboratory results.
• Maintains laboratory notebooks, worksheets, electronic records, files, and supporting documentation in compliance with current GMPs, SOPs, and data integrity requirements.
• 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.

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.

What Ardena Offers

• 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.