Microbiologist III

Penn Life Sciences is seeking a Microbiologist III to join our team in Langhorne, PA.

The Microbiologist III will serve as a senior-level technical expert supporting microbiological testing, aseptic process control, and contamination prevention for sterile and oral solid dosage manufacturing. This role provides advanced oversight of microbiological methods, data review, and laboratory operations to ensure product quality and regulatory compliance under cGMP requirements. The ideal candidate will bring extensive experience in aseptic processing, environmental monitoring, and microbiological method validation, as well as the ability to mentor junior staff and serve as a subject matter expert during audits and inspections.

This position’s responsibilities will include, but not be limited to the following:

• Perform and review complex microbiological assays including sterility, endotoxin, bioburden, and microbial limits testing for GMP products and stability samples.
• Lead environmental and personnel monitoring programs for aseptic cleanrooms and critical utilities, ensuring control and trending of microbial data.
• Plan, execute, and document validation studies for sterilization, depyrogenation, and aseptic process simulations (media fills).
• Review and approve laboratory investigations, deviations, and CAPAs, ensuring root cause identification and timely implementation of corrective actions.
• Develop, revise, and approve microbiology-related SOPs, test methods, and technical reports to ensure regulatory readiness.
• Provide technical guidance and mentorship to junior microbiologists, promoting best practices in aseptic technique, documentation, and contamination control.

We are looking for applicants with:

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related life-science discipline required; Master’s degree preferred.
• 7–10 years of progressively responsible microbiological or quality control experience in a GMP-regulated pharmaceutical, biotechnology, or sterile manufacturing environment.
• Demonstrated expertise in aseptic processing, environmental monitoring, microbiological method validation, and contamination control.
• Strong understanding of regulatory requirements including 21 CFR Parts 210–211, USP <61>, <62>, <85>, <71>, and related microbiological standards.
• Advanced ability to analyze and trend data, lead investigations, and implement effective CAPAs.
• Proficiency with laboratory information systems (LIMS, MODA) and electronic documentation platforms.
• Excellent written, verbal, and technical communication skills for documentation, audit interactions, and cross-functional collaboration.
• Proven ability to mentor staff, manage multiple priorities, and support inspection readiness within a dynamic, fast-paced environment.

What we offer:

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.