Position Overview
We are seeking an experienced Microbiology Team Lead to oversee microbiological activities. The quality team will be working with the safety of sterile injectable products. This leadership role will guide a team of microbiology professionals in testing, environmental monitoring, contamination control, and regulatory compliance in a fast-paced, GMP-regulated environment.
Key Responsibilities
- Supervise and coordinate all microbiological testing activities, ensuring timely completion in line with organizational goals.
- Review and authorize batch documentation, raw material results, and stability data, ensuring adherence to regulatory standards.
- Lead, mentor, and develop the microbiology team, providing both technical direction and performance support.
- Manage and resolve lab investigations, deviations, change controls, SOP updates, and trending reports within the department.
- Ensure strict compliance with GMP, GLP, and applicable global regulatory requirements while embedding best practices into daily operations.
- Oversee the calibration and maintenance of laboratory equipment and instruments.
- Maintain and validate microbiological test methods and ensure their ongoing suitability for use.
- Serve as a deputy for the Microbiology Laboratory Manager, supporting departmental oversight and decision-making processes.
- Administer the environmental monitoring program and lead root cause analysis and corrective actions for out-of-specification results.
- Manage aseptic process simulations (media fills), including scheduling, documentation review, and approvals.
- Contribute to the development and execution of contamination control strategies and support regulatory audits and inspections.
Qualifications & Experience
We're looking for candidates with a strong blend of technical expertise and leadership capabilities. Ideal applicants will have:
- A Bachelor's degree (or equivalent) in Microbiology, Biology, or a related scientific field.
- 2-4 years of relevant industry experience.
- Minimum 1 year experience in a position of leadership.
- Familiarity with isolator technology and digital systems.
- Direct experience in sterile injectable manufacturing, aseptic processing, and contamination control.
- Excellent leadership, communication, and problem-solving abilities.