Role & responsibilities

Purpose:

To lead the Microbiology section by managing a team of 10+ analysts and reviewers to ensure timely batch analysis, data verification, and product releases. This role drives lab automation projects, manages QMS compliance, and maintains a continuous state of audit readiness under strict GLP and EHS guidelines.

Responsibilities

- Lead and manage a team of approx. 10+ members (Analysts + Reviewers) in the Microbiology section to ensure timely batch releases and target completions.
- Oversee the comprehensive review of microbiological raw data for accuracy and completeness before final submission to respective departments.
- Drive and execute laboratory automation projects, taking full technical ownership from implementation to successful completion.
- Manage the full lifecycle of section-specific QMS tasks including incidents, investigations, file notes, ratifications, OOS, OOT, Change Controls, and CAPAs within deadlines.
- Ensure optimal allocation of all lab resources including chemicals, reagents, growth media, reference standards, and cultures for uninterrupted operations.
- Demonstrate strong, self-driven decision-making capabilities to lead the Microbiology section independently with minimal supervisory support.
- Front-face international regulatory and client audits (USFDA, MHRA, etc.), defending all microbiology testing and data tracking workflows.
- Actively participate in departmental continuous improvement programs to systematically enhance operational quality, safety, and testing output.
- Enforce absolute compliance with Good Laboratory Practices (GLP) and Health, Safety, and Environment (EHS) requirements across the laboratory.
- Execute specialized analytical tasks, cross-plant travel assignments,



and strategic directives assigned by the HOD or Senior Leadership.

Required Skills

- Microbial Testing Expertise: Proficient in MLT, Water Analysis, Environmental Monitoring (EM), and operating instruments like horizontal autoclaves, water activity meters, and balances.
- QMS & Root Cause Investigation: Strong capability to investigate laboratory events, perform root cause analysis, and draft robust OOS/OOT compliance reports.
- Automation Implementation: Proven skill in leading, troubleshooting, and adopting modern digital systems or automated technologies inside a pharma lab framework.
- Leadership & Audit Defense: Excellent team management capabilities to guide 10+ members and the communication skills required to confidently face USFDA/MHRA auditors.
- Operational Flexibility: Self-driven learning agility with the physical and operational flexibility to balance multi-shift schedules and multi-site travel priorities.

Preferred Candidate Details

- Education: Masters Degree in Microbiology from a recognized university with an overall experience range suited for a section head role.
- Industry Background: Proven track record in a USFDA / MHRA approved pharmaceutical formulation facility with solid exposure to global GMP-GLP practices.
- Team Supervision: Direct experience leading and mentoring a blended team of at least 10 analysts and technical data reviewers simultaneously.
- Data Verification: Expert-level capability in electronic and manual analytical data review, ensuring absolute compliance with current data integrity frameworks.
- Shift & Travel Readiness: Mandatory flexibility to work in all rotational shifts and travel across different plant locations based on urgent company priorities.

📌 Assistant Manager - Microbiology (Mumbai)
🏢 Rubicon Research
📍 Mumbai