Microbiology - AM/DM

Role & responsibilities

• Testing & Monitoring: Oversee and perform microbiological testing of raw materials, purified water (PW), Water for Injection (WFI), compressed gases, in-process samples, and finished products.
• Environmental Monitoring (EM): Manage cleanroom EM programs for Grade A, B, C, and D sterile areas (air sampling, surface monitoring, and personnel swabbing) and conduct trend analysis.
• Specialized Assays: Ensure accurate execution of sterility testing, Bacterial Endotoxin Tests (BET/LAL), Microbial Limit Testing (MLT), Bioburden Limit Testing (BLT), growth promotion tests, and media preparation.
• Investigations & QMS: Handle Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations, root-cause analyses, Corrective and Preventive Actions (CAPA), and change controls.
• Documentation & Compliance: Review and approve Standard Operating Procedures (SOPs), protocols, and laboratory records to ensure alignment with cGMP, GLP, WHO, USFDA, EU GMP, and Data Integrity (ALCOA+) standards.
• Audits & Team Management: Lead or support regulatory inspections (USFDA, MHRA), customer/internal audits, mentor junior analysts, and manage day-to-day lab operations.

Required Qualifications & Experience

• Education: M.Sc. in Microbiology / Biotechnology / Life Sciences (or B.Pharm / M.Pharm depending on company specs; B.Sc. Microbiology with extensive injectable experience may also qualify).
• Experience: Generally 8 to 15 years of hands-on experience in sterile injectable microbiology within a USFDA/EU-regulated manufacturing facility, including supervisory or team-handling experience.
• Key Skills: Environmental Monitoring, Sterility Testing, BET, MLT, Water Analysis, LIMS/QMS software handling, and deep knowledge of regulatory compliance.