QC Microbiology Laboratory Manager
The Microbiology Lab Manager will oversee the microbiology function. A major focus for this position is managing the GMP environmental monitoring (EM) program which includes several production suites of ISO class 5, 7, and 8 as well as EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). In addition, monitoring of purified water, and compressed gases systems is required. Responsibilities include EM data review, evaluation, reporting, and trending of data; investigations; scheduling in house and contract personnel; gowning training and annual gowning qualification. The microbiology lab manager must have experience in room qualification (per ISO 14644), site location selection using risk analysis, cleaning validation contamination control and must ensure that the EM program meets regulatory and industry standards. The manager must provide general microbiological expertise including, gram staining, isolate identification and creating and managing a library of facility isolates.
- Perform and/or oversee environmental monitoring for HVAC (viable air, viable surface, total particulates), personnel monitoring, purified water (conductivity, TOC, bioburden) and compressed gases (hydrocarbon, dew point and bioburden) systems. Serve as subject matter expert in this area.
- Must have experience in room qualification (per ISO 14644), site location selection using risk analysis, cleaning validation and must ensure that the EM program meets regulatory and industry standards.
- Provide direct supervision to analysts including: scheduling, setting goals and objectives, training and ensuring development plans are in place. Address personnel issues promptly, interview and hire new candidates and complete performance reviews fairly and on-time.
- Review and trend EM data and publish quarterly and annual trend reports.
- Schedule testing and review data for accuracy, adherence to compliance and completeness.
- Conduct thorough investigations to determine root cause of environmental excursions and other nonconforming results and implement appropriate corrective and preventative actions in a timely manner.
- Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
- Understand and apply current regulations (cGMP and EU).
- Perform microbiological testing such as bioburden, endotoxin, growth promotion, viability and gram staining, etc.
- Establish and maintain library of environmental isolates.
- Provide microbiological expertise to QC and to other departments as needed. Act as point of contact for training and qualifications.
- Perform or assist with the development and implementation of microbiological methods.
- Perform QC Laboratory testing accurately and to schedule as per written procedures. Record all data, observations and QC results accurately with keen attention to detail onto controlled records to cGMP standards.
- Participate in client and internal audits, client calls and meetings. Address client requests and audit findings in a timely and appropriate manner.
- Participate in assay troubleshooting, qualification and validation.
- Oversee submission of samples to contract testing laboratories.
- Order and maintain laboratory reagents and supplies.
- Manage the use and maintenance of scientific equipment and instrumentation, computer systems; Ensure that they are kept in a calibrated / validated state and part 11 compliant.
- Maintain high level of cleanliness, organization and segregation in the QC Laboratory.
- Write and revise documents such as SOPs and technical reports.
- Assist in making continuous improvements to the QC systems.
- Perform other tasks as required or assigned.
- B.A. or B.S. or MS degree in microbiology or related scientific field
- A minimum of 10-12 years related microbiology experience with biological products, in a GMP Quality Control laboratory.
- Experience performing EM, purified water and compressed gases sampling and testing for ISO classes 5, 7 and 8 as well as EU Grade A to D.
- Experience with bioburden testing and qualification required.
- Requires excellent written and verbal communication skills. Must be able to analyze data and write summary reports.
- Proven and demonstrated computer (PC) and software skills including MS Office Suite Excel and Word programs.
- Must have experience with cGMP and quality systems including OOS and EM investigations, deviations, change control and CAPAs.
- High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
- Demonstrated ability to work independently as well as be a strong team contributor.
- Must be able to lift up to 25 lbs with or without reasonable accommodations