Senior Principal Microbiologist – Quality Control

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing

If you’re looking for a rewarding career, apply with us today

Eurofins PSS is seeking a highly experienced QC Microbiologist SME to support pharmaceutical quality control operations at a client site. This individual will serve as the primary microbiology expert in the lab, acting as the go-to resource for all QC microbiology-related inquiries. While this is not a formal leadership role, there is potential for future advancement into leadership.

The successful candidate will be responsible for training team members, updating procedures, performing critical testing, and leading investigations into non-conformances. This role requires deep technical expertise and the ability to work independently in a GMP-regulated environment.

Key Expertise Required:

• Sterility and Endotoxin Testing (including BacT rapid sterility assay)
• USP Standards
• Growth Promotion Testing, Gram Staining
• Environmental Monitoring of Pharmaceutical Labs and Cleanrooms
• Aseptic Process Media Fills
• cGMP Compliance
• Cell Therapy Experience (preferred)

Responsibilities:

• Perform sterility, endotoxin, pH, and osmolality testing on raw materials, drug substances, and drug products.
• Conduct gram stains, isolate sub-culturing, growth promotion testing, and general cell culture work.
• Coordinate and execute testing aligned with manufacturing schedules.
• Lead and support Aseptic Processing Media Fills, including visual inspection.
• Maintain lab cleanliness, equipment upkeep, and accurate logbook documentation.
• Support daily QC operations and collaborate with cross-functional departments (Manufacturing, QA, Facilities).
• Author and revise SOPs, change controls, qualification protocols, and reports.
• Investigate Out of Specification (OOS) results, identify root causes, assess impact, and implement CAPAs.
• Ensure data integrity and compliance with Good Documentation Practices and ALCOA++ principles.
• Perform internal audits and GEMBA walk-throughs to uphold compliance standards.
• Conduct viable and non-viable environmental monitoring (air, surface, personnel, particulate).
• Oversee critical aseptic manufacturing steps to ensure accuracy and compliance.
• Train and mentor other employees as needed.

• Bachelor’s degree in a scientific discipline.
• Minimum of 4 years of microbiology experience in a GMP pharmaceutical or biologics environment.
• Proven expertise in sterility testing, endotoxin testing, growth promotion, aseptic media fills, and environmental monitoring.
• Experience with cell therapy and mammalian cell culture preferred.
• Strong knowledge of cGMPs, GDPs, and industry standards.
• Familiarity with lab equipment (microscopes, pH meters, incubators).
• Excellent verbal and written communication skills.
• Willingness to work occasional off-shift or weekend hours.
• Ability to work independently and train others effectively.

What to Expect in the Hiring Process: 

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

Additional Details: 

Position is Full Time, Monday – Friday First Shift with support outside of standard hours. Candidates currently living within a commutable distance of Exton, PA are encouraged to apply.

Excellent full-time benefits include:

• comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.