Job Details
Position Summary
The newly formed Quality team is seeking a Microbiology Manager to oversee critical aspects of the GMP facility's environmental monitoring and contamination control program. Reporting directly to the QC Director, the Microbiology Manager will ensure the facility's compliance by qualifying and maintaining its GMP status, conducting aseptic process simulations, managing disinfection procedures and practices, validating cleaning processes, and overseeing microbiological testing throughout production stages.
In addition to governance responsibilities, the Microbiology Manager will lead the development and implementation of activities in the microbiology laboratory to align with production objectives while meeting quality standards and cost targets. Expertise in contamination control methodologies within pharmaceutical or biological industries is essential for this role.
Collaboration is key, as the Microbiology Manager will work closely with Quality, Manufacturing, and Process Sciences teams to ensure alignment with global regulatory standards and business objectives. Representing the company internally and externally, this position contributes to fostering a culture of quality.
Duties & Responsibilities:
- Communicates contamination control and Sterility Assurance practices effectively to team members
- Aligns team objectives with Company strategic goals and programs
- Manages and meets milestones for key Company projects
- Implements systems for achieving recognized aseptic excellence
- Acts as primary subject matter expert in Microbiology, aseptic processing, and Contamination Control risk assessment and mitigation
- Collaborates with Facilities, manufacturing, and operations support teams on disinfection procedures/practices
- Oversees project completion, including scheduling, planning, and reporting for laboratory and contamination control systems
- Manages Gowning Qualification and Training Program
- Coordinates QC personnel activities in environmental sample collection, processing, and data evaluation
- Oversees shipment and testing of microbial samples contracted to CTOs
- Assigns analysts to testing functions and conducts tests when necessary
- Supports, mentors, and trains sterility assurance owners in contamination control processes and best practices
- Provides leadership for laboratory test/method validation and qualification of media and disinfectants
- Supports day-to-day contamination control functions and initiatives, including staffing and quality control of test methods
- Leads investigations into environmental excursions and assists with CAPAs
- Conducts root cause analysis of product/process failures and suggests improvements
- Develops, writes, and revises SOPs
- Recommends implementation of new laboratory equipment
- Maintains thorough documentation of environmental monitoring studies and performs data trending
- Stays updated on relevant regulations affecting the role
- Performs other assigned duties
Experience:
- Bachelor s degree with 7 to 8 years of experience, or Master s degree with 5 years of experience in microbiology (preferred).
- Demonstrated ability to lead, coach, and motivate employees, with a minimum of three years in a management position.
- Strong knowledge of pharmaceutical microbiology and contamination control.
- Sound understanding of aseptic processing and related technologies.
- Minimum of 5 years of experience in cleanroom facility and microbial rapid test methods validation.
- Previous involvement in non-conformances and corrective action and preventive action processes.
- Experience in writing and reviewing technical documentation.
- Practical knowledge of GMP facility qualification and Aseptic Process Simulation.