Position Overview
The Executive Microbiologist is responsible for execution, review, and compliance of microbiological testing activities for raw materials, in‑process samples, finished products, utilities, cleanrooms, and sterile/non‑sterile environments in line with USFDA, cGMP, and global regulatory requirements. The role ensures microbiological control, regulatory compliance, and audit readiness for OSD manufacturing operations.
Key Responsibilities
Routine Microbiological Testing - Perform and review microbiological analysis of raw materials, finished products, stability samples, and packing materials (as applicable).
- Handle bioburden testing, microbial limit tests (MLT), pathogen testing, and sterility‑related support activities (where applicable).
- Conduct water system testing including Purified Water and Drinking Water (chemical & microbiological support).
Environmental Monitoring & Utilities - Execute and trend Environmental Monitoring (EM) of production areas (OSD): viable and non‑viable monitoring.
- Perform sampling and analysis of compressed air, gases, surface, personnel, and utilities.
- Review EM data, identify trends, and initiate deviations/CAPAs where required.
Media & Culture Handling - Preparation, sterilization, dilution, and qualification of culture media.
- Perform media growth promotion tests (GPT).
- Proper handling, storage, and disposal of microbial cultures as per biosafety norms.
Documentation & GMP Compliance - Prepare, review, and maintain documentation such as:
- Test reports
- Logbooks
- SOPs
- Deviations, OOS, OOT, and CAPAs
- Ensure compliance with cGMP, ALCOA+, data integrity, and laboratory SOPs.
- Maintain laboratory housekeeping, calibration, and cleanliness of microbiology lab.
Audit & Regulatory Support - Support USFDA, MHRA, WHO, and internal audits.
- Prepare and present microbiology data during inspections.
- Assist in investigation and response to audit observations related to microbiology and contamination control.
Validation & Qualification Support - Participate in cleanroom qualification and requalification.
- Support validation activities for water systems, disinfectants, cleaning procedures, and microbiology test methods.
- Execute method verification/validation activities as required.
Qualifications & Experience
Education - M.Sc. in Microbiology / Applied Microbiology / Biotechnology or equivalent
Experience - 5–8 years of hands‑on experience in QC Microbiology within a USFDA‑approved OSD manufacturing facility
- Strong exposure to regulatory audits and GMP practices
Technical & Regulatory Knowledge
- In‑depth knowledge of:
- USFDA, cGMP, ICH, WHO guidelines
- Microbial limits testing & EM programs
- Data Integrity & GDP
- Familiar with pharmacopeias: USP, EP, IP
- Good understanding of contamination control strategies
Key Competencies
- Strong analytical and documentation skills
- Ability to handle audit queries confidently
- Team coordination and communication skills
- Detail‑oriented with a compliance mindset
Preferred Skills
- Experience handling USFDA inspections
- Exposure to data integrity remediation
- Leadership capability to guide junior microbiologists
