Job Title: Microbiology Team Lead
We are seeking an experienced professional to oversee microbiological activities, ensuring the quality team meets stringent standards for sterile injectable products.
This leadership role guides 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:
* 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.