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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Responsibility:
Lead daily lab operations—including oversight of environmental monitoring, microbial testing of utilities (USP <61>, <62>, <85>), and in-process/final product testing
Supervise, mentor, and develop a high-performing team of microbiologists and lab personnel
Manage scheduling, workloads, and ensure timely testing and release of all microbiological samples
Perform risk assessments and investigations (EM excursions, aseptic incidents) and implement effective CAPAs
Perform data trending and statistical analysis
author quarterly reports on environmental and utility data
Oversee testing for endotoxins, bioburden, growth promotion, EM sampling, and clean utility sampling
Collaborate cross-functionally with Operations and Facilities to protect aseptic integrity
Support and coordinate equipment validation, calibration, and maintenance
Drive compliance with cGMP, FDA, EU, and international microbiology regulations
Review and author SOPs, support method development, and guide test execution to regulatory expectations
Requirements:
Master’s degree in Microbiology, Biology, or related life science (preferred)
Bachelor’s degree with 5+ years of progressive GMP QC Microbiology experience
1–3+ years in a leadership role within a QC Microbiology lab
Hands-on experience with aseptic processing, environmental monitoring, and USP microbiological testing required
Skilled in data analysis and report writing
Must be able to work across NH PCI sites, including remote locations
Ability to gown for ISO-classified cleanroom work
Ability to lift up to 20 lbs
Occasional off-shift support may be required
Nice to have:
In-depth understanding of ISO cleanroom classifications and GMP clean utility systems
Strong knowledge of U.S. and international microbiology regulations
Experience with media qualification, microbial identification, and root cause investigations
What we offer:
Opportunities for growth and advancement within a science-driven, patient-focused organization
A collaborative, team-oriented environment with cross-functional exposure
The chance to make an impact on public health by ensuring the safety of every batch
Ongoing training and development to keep your skills sharp in a fast-evolving industry