GMP Microbiology Lab Supervisor - Lead & Improve Quality

PSC Biotech; York (York County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & vision

Dental insurance

Life Insurance

401(k) match

PTO & holidays

Education assistance

Pet insurance

Wellness perks

Discounts

Job summary

BioTechnique, a sterile injectable CDMO in York, is seeking a Microbiology Supervisor to oversee daily lab operations, ensuring GMP/GLP compliance and supporting testing of raw materials, in-process samples, and finished products.

The role provides leadership to microbiology staff, ensures timely and accurate results, and maintains adherence to regulatory standards. Collaboration with QA, Manufacturing, and R&D is essential.

Qualifications

• Bachelor’s degree in Microbiology or related scientific discipline required; Master’s degree preferred.
• 5+ years of experience in a GMP-regulated microbiology laboratory.
• 2+ years of supervisory or leadership experience.
• Experience in the pharmaceutical, biotechnology, or life sciences industry is required.
• Strong knowledge of microbiological techniques (environmental monitoring, sterility testing).
• In-depth understanding of cGMP, FDA, USP <61>, <62>, <71>, and other relevant guidelines.

Responsibilities

• Oversee day-to-day microbiology laboratory activities and regulatory compliance.
• Lead environmental monitoring, sterility testing, microbial identification, and bioburden testing.
• Review laboratory data and approve test results for accuracy and completeness.
• Lead investigations for OOS, deviations, and contamination; implement CAPA.
• Maintain laboratory readiness for audits and inspections.
• Develop, revise, and approve SOPs, protocols, and reports; train and evaluate staff.
• Ensure calibration & qualification of laboratory equipment.
• Coordinate sample scheduling and ensure timely testing to meet production/release timelines.
• Monitor laboratory inventory, reagents, and supplies.
• Support method validation and transfer; drive continuous improvement.
• Collaborate with QA, Manufacturing, and R&D teams.

Skills

GMP compliance

GLP knowledge

cGMP knowledge

FDA/USP knowledge

Leadership

Problem solving

Data integrity

Education

Bachelor’s in Microbiology/Biology/Biochemistry

Master’s degree preferred

Job description

BioTechnique, a sterile injectable CDMO in York, is seeking a Microbiology Supervisor to oversee daily lab operations, ensuring GMP/GLP compliance and supporting testing of raw materials, in-process samples, and finished products.

The role provides leadership to microbiology staff, ensures timely and accurate results, and maintains adherence to regulatory standards. Collaboration with QA, Manufacturing, and R&D is essential.