
Senior QC Microbiologist – SME
- Exton, PA
- Permanent
- Full-time
- Perform sterility, endotoxin, pH, and osmolality testing on raw materials and drug products.
- Conduct gram stains, growth promotion testing, and cell culture work.
- Lead aseptic process media fills and related testing (e.g., visual inspection).
- Carry out environmental monitoring (air, surfaces, personnel, particulates) in cleanrooms.
- Keep lab equipment clean and maintained; ensure documentation is complete and compliant.
- Write and update SOPs, change controls, and qualification protocols.
- Investigate out-of-specification (OOS) results and non-conformances; identify root causes and implement corrective actions.
- Perform internal audits and walk-throughs to ensure compliance.
- Collaborate with Manufacturing, QA, and Facilities teams to meet production goals.
- Train other lab staff as needed.
- Sterility and endotoxin testing
- USP standards
- Growth promotion and gram staining
- Environmental monitoring in pharma settings
- Aseptic process media fills
- cGMP and Good Documentation Practices
- Bachelor’s degree in a scientific field (e.g., Microbiology, Biology)
- At least 4 years of microbiology experience in a GMP pharmaceutical or biologics environment
- Strong experience with BacT rapid sterility assay, endotoxin testing, growth promotion, and aseptic processing
- Experience with mammalian cell culture and aseptic manufacturing
- Familiarity with lab equipment like microscopes, pH meters, and incubators
- Excellent communication skills and ability to work independently
- Willingness to work occasional off-shifts and weekends
- Ability to train and support other team members
- 10-15 Minute Phone Interview with Region Recruiter
- 45-60 Minute Virtual Interview with Manager and/or Group Leader
- 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