Senior Microbiology Lab Lead – GMP & Regulatory

Jubilant Pharma, LLC; Caen; On-site; EUR 115,000 - 153,000; Full time

Job summary

Jubilant Radiopharma seeks a seasoned microbiology leader to oversee the microbiology laboratory, regulatory compliance, and continuous quality improvements. You will guide environmental monitoring, aseptic operations, and investigations to protect finished products and manufacturing environments.

You will collaborate with Production, QA, and Validation, provide mentorship to the team, and act as SME during regulatory inspections by Health Canada, FDA, and EMA as applicable.

Qualifications

• B.Sc. or M.Sc. in Microbiology or related discipline.
• Minimum ten years in pharma microbiology lab.
• Experience in a sterile environment.
• Supervisory experience in pharma microbiology.
• Strong knowledge of environmental monitoring.
• Experience with cGMP for sterile parenteral products.

Responsibilities

• Lead daily microbiology lab operations and develop a high-performing team.
• Ensure GMP/cGMP compliance and regulatory readiness.
• Write and review impact assessments, protocols, and reports.
• Oversee EM program and environmental monitoring.
• Support method development, transfer, and validation.
• Lead investigations of OOS results and CAPA.

Skills

Microbiology

Leadership

Regulatory compliance

Environmental monitoring

Aseptic operations

cGMP knowledge

SOP documentation

Cross-functional

Education

B.Sc. or M.Sc. in Microbiology

Tools

SAP

Microsoft Office

Job description

Jubilant Radiopharma seeks a seasoned microbiology leader to oversee the microbiology laboratory, regulatory compliance, and continuous quality improvements. You will guide environmental monitoring, aseptic operations, and investigations to protect finished products and manufacturing environments.

You will collaborate with Production, QA, and Validation, provide mentorship to the team, and act as SME during regulatory inspections by Health Canada, FDA, and EMA as applicable.