Senior Principal Microbiologist - Quality Control

What You’ll Do: Perform sterility, endotoxin, pH, and osmolality testing on raw materials and drug products. Conduct gram stains, growth promotion testing, sub-culturing, and basic cell culture work. Lead and support Aseptic Process Media Fills, including visual inspections and documentation. Schedule and coordinate testing based on manufacturing timelines. Maintain lab cleanliness, equipment, and proper documentation. Write and update SOPs, change controls, qualification protocols, and reports. Investigate Out of Specification (OOS) results and lead root cause analysis and CAPA implementation. Ensure data integrity and follow Good Documentation Practices (GDP) and ALCOA++ principles. Perform internal audits and GEMBA walk-throughs to ensure compliance. Collaborate with Manufacturing, QA, and Facilities teams to meet production goals. Conduct environmental monitoring (air, surface, personnel, particulate) in cleanrooms. Oversee critical steps during aseptic manufacturing to ensure accuracy. Train and mentor other lab staff as needed.

Qualifications: Bachelor’s degree in a scientific field. 4+ years of microbiology experience in a GMP pharmaceutical or biologics environment. Deep expertise in: Sterility and endotoxin testing USP standards Growth promotion and gram staining Environmental monitoring Aseptic process media fills cGMP and GDP compliance Experience with BacT rapid sterility assay and cell therapy is a plus. Familiarity with lab equipment like microscopes, pH meters, and incubators. Strong communication skills and ability to work independently. Willingness to work occasional off-shifts or weekends.

Additional Information: 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. 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 insourcing solution that places our people at client sites, dedicated to running and managing laboratory services while supporting client quality systems and equipment. For more information, visit www.eurofinsus.com. Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer, including for Disabled and Veterans.