Manager, QC Microbiology (Sterile Drug Manufacturing & Fill Finish)
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Job Location:
Danbury, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
MannKind Corporationfocuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes nontuberculous mycobacterial (NTM) lung disease pulmonary fibrosis and pulmonary signature technologies dry-powder formulations and inhalation devices offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation depending on the target indication.
Position Overview
The QC Microbiology Manager leads the daily operations of the Microbiology Laboratory supporting sterile drug product manufacturing and fillfinish operations. This role ensures that environmental monitoring microbiological testing and contamination control programs meet regulatory expectations and maintain a state of control across aseptic processing areas. The ideal candidate brings strong technical expertise in microbiology proven leadership skills and deep understanding of sterile manufacturing and fillfinish processes.
Key Responsibilities
Microbiology Laboratory Leadership
- Supervise and mentor microbiologists and laboratory analysts ensuring high technical competency and adherence to cGMP.
- Oversee scheduling workload prioritization and resource planning to support manufacturing and fillfinish operations.
- Ensure laboratory operations comply with FDA EMA ICH and Annex 1 requirements.
- Maintain a culture of data integrity continuous improvement and operational excellence.
Aseptic & FillFinish Support
- Serve as a technical lead for Aseptic Process Simulations (Media Fills). This includes designing worst-case simulation protocols managing the incubation and inspection of units and investigating any failures to identify root causes.
- Provide microbiology expertise for aseptic processing sterile filtration filling operations lyophilization and visual inspection.
- Lead oversight of environmental monitoring (EM) programs for cleanrooms isolators RABS and filling suites.
- Review and approve EM trend reports sterility test results bioburden data endotoxin results and water system monitoring.
- Partner with Manufacturing QA and Engineering to ensure contamination control strategies are robust and effective.
Compliance Investigations & Quality Systems
- Lead or support investigations for microbiologyrelated deviations EM excursions sterility failures and contamination events.
- Develop and implement CAPAs to prevent recurrence and strengthen contamination control.
- Review and approve SOPs test methods validation protocols and laboratory documentation.
- Support regulatory inspections and internal audits serving as the subject matter expert for microbiology and aseptic controls.
- Ensure qualification and ongoing monitoring of clean utilities (WFI clean steam compressed gases).
Laboratory & Method Management
- Oversee qualification calibration and maintenance of microbiology laboratory equipment (e.g. isolators incubators endotoxin systems).
- Ensure validated and compliant microbiological test methods including sterility testing endotoxin bioburden microbial ID and growth promotion.
- Manage sample flow chain of custody and timely release of microbiological data to support production schedules.
- Drive continuous improvement initiatives to enhance testing efficiency contamination control and laboratory workflow.
Qualifications
- Bachelors or masters degree in microbiology Biology or related Life Science discipline.
- 10 years of QC Microbiology experience with at least 2 years in a supervisory or management capacity in a GMP sterile drug manufacturing environment.
- Direct experience with media fill validation smoke studies and environmental monitoring in Grade A/B (Class 100) environments.
- Strong knowledge of aseptic processing contamination control and fillfinish operations.
- Experience with environmental monitoring programs sterility testing Bacterial Endotoxin Testing and cleanroom classification.
- In-depth understanding of the 2022 revised EU Annex 1 FDA 21 CFR 211 USP <71> <85> and <1116> and ICH Q7Q10.
- Demonstrated leadership experience including coaching training and performance management.
- Excellent communication documentation and crossfunctional collaboration skills.
Preferred
- Experience with isolatorbased sterility testing and aseptic filling technologies.
- Knowledge of rapid microbiological methods (RMM) and modern contamination control strategies.
- Experience supporting regulatory inspections (FDA EMA MHRA).
- Understanding of water system microbiology and clean utility qualification.
- Lean/Six Sigma or continuous improvement training.
Required Experience:
Manager
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
