Senior Microbiologist, GMP & Lab Compliance

piramalpharma; Lexington (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions in Lexington seeks a Senior Microbiologist to serve as subject matter expert for audits, data reviews, and lab expansion projects. The role reports to the Microbiology Manager and supports cGMP compliance.

The candidate will lead SOPs, test methods, CAPAs, and risk assessments while training staff and collaborating with Quality Assurance to ensure robust microbiology operations and regulatory readiness.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field.
• 5-7 years of Experience in high throughput Microbiology Laboratories in a GMP environment (parenterals/CMO/CDMO).
• Knowledge of cGMP and pharmaceutical industry expectations.
• Experience with microbiology techniques and laboratory instrumentation.

Responsibilities

• Prepare, review, and approve SOPs, Test Methods, Protocols, Reports, Trending Reports, Data Review, CCRs, CAPAs, Risk Assessments.
• Provide cGMP and lab training to staff and troubleshoot lab practices.
• Lead laboratory investigations, deviations, and CAPA implementation; write/review SOPs.
• Provide data and QA input during inspections or regulatory inquiries as needed.
• Support process improvements and lab expansion projects.
• Develop and implement microbiology lab procedures with QA.
• Participate in environmental monitoring, cleaning validation, and related tests.

Education

B.S. in Microbiology

Tools

Autoclaves

Air samplers

Light microscope

Biohazard cabinets

Water purification system

Job description

Piramal Pharma Solutions in Lexington seeks a Senior Microbiologist to serve as subject matter expert for audits, data reviews, and lab expansion projects. The role reports to the Microbiology Manager and supports cGMP compliance.

The candidate will lead SOPs, test methods, CAPAs, and risk assessments while training staff and collaborating with Quality Assurance to ensure robust microbiology operations and regulatory readiness.