Kincell Bio is seeking a highly motivated and experienced QC Microbiology Supervisor to provide technical leadership and day-to-day oversight of microbiology and environmental monitoring activities supporting GMP manufacturing operations. This position will play a critical role in establishing and maintaining the microbiological state of control of Kincell Bio's manufacturing and laboratory environments.
The QC Microbiology Supervisor will lead routine environmental monitoring and microbiological testing activities while remaining hands-on and maintaining proficiency across the laboratory's testing portfolio. The position will provide technical oversight of microbiology personnel, support investigations and contamination control activities, review and trend microbiological data, coordinate external laboratory testing, and contribute to the qualification and validation of microbiology methods, equipment, and processes.
Essential Dutiesand ResponsibilitiesReasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
- Provide day-to-day leadership, technical direction, and oversight of QC microbiology and environmental monitoring activities supporting GMP manufacturing operations.
- Coordinate and prioritize microbiology workload to ensure timely completion of environmental monitoring, QC testing, investigations, and other laboratory activities.
- Serve as a hands-on technical resource and primary backup for microbiological testing activities, maintaining proficiency in applicable microbiological methods, including sterility, bacterial endotoxin, bioburden, growth promotion, environmental monitoring, compressed gas testing, microbial identification, Gram staining, and other applicable assays.
- Perform microbiological testing as needed to support laboratory workload, manufacturing schedules, investigations, staffing requirements, and off-hours or weekend coverage.
- Oversee environmental monitoring activities, including viable air, surface, personnel, compressed gas, and other applicable monitoring within classified cleanrooms and laboratory areas.
- Coordinate microbiological testing performed by external contract laboratories, including sample submission, test requirements, result review, and reconciliation of final reports.
- Oversee and perform microbiological media preparation, growth promotion testing, and media qualification in accordance with approved procedures and applicable compendial requirements.
- Provide technical oversight and hands-on support for sterility testing, method verification, and method suitability activities, including testing performed using the BacT/ALERT 3D System.
- Ensure microbiology laboratory equipment is appropriately maintained, calibrated, qualified, and available for intended use.
- Lead and/or support microbiology investigations, including environmental monitoring excursions, atypical results, out-of-specification events, and other microbiological events.
- Support root cause analysis, product and facility impact assessments, corrective and preventive actions, and effectiveness evaluations associated with microbiological events.
- Develop, review, and execute microbiology protocols, investigations, reports, technical assessments, and other controlled documentation.
- Support qualification and validation activities for microbiology equipment, processes, facilities, and analytical methods, including protocol development, execution, data review, and report generation.
- Review microbiology records, analytical data, protocols, reports, and other controlled documentation for accuracy, completeness, compliance, and data integrity.
- Analyze and trend microbiological and environmental monitoring data to identify potential adverse trends, recurring events, or opportunities for improvement.
- Train, mentor, and qualify microbiology personnel and provide ongoing technical coaching to ensure personnel maintain required competencies.
- Coordinate daily laboratory activities and provide technical guidance to microbiology personnel to ensure appropriate execution of testing and adherence to established procedures.
- Maintain the microbiology laboratory in a clean, orderly, compliant, and inspection-ready state.
- Collaborate with Quality Assurance, Manufacturing, Engineering, Validation, and other cross-functional groups to support manufacturing operations, investigations, contamination control, qualification activities, and continuous improvement initiatives.
- Participate in internal audits, regulatory inspections, and other quality assessments as a microbiology subject matter expert, as applicable.
- Identify and implement opportunities to improve microbiology laboratory processes, testing efficiency, environmental monitoring practices, contamination control, and overall laboratory performance.
- Ensure compliance with company policies, procedures, SOPs, GMP requirements, applicable regulatory expectations, and data integrity principles.
QualificationsThe requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Required:
- Bachelor's degree in Microbiology, Biology, or another relevant scientific discipline and a minimum of 4 years of relevant microbiology laboratory experience in a GMP-regulated environment.
- Demonstrated experience performing and/or overseeing microbiological testing and environmental monitoring in a GMP-regulated environment.
- Hands-on experience with aseptic gowning and working within classified cleanroom environments.
- Demonstrated proficiency in microbiological testing, including sterility, bacterial endotoxin, growth promotion, bioburden, microbial enumeration, subculture techniques, environmental monitoring, compressed gas testing, microbial identification, and Gram staining.
- Experience with microbiology investigations, including environmental monitoring excursions, atypical results, out-of-specification events, root cause analysis, and impact assessments.
- Experience developing, executing, reviewing, and documenting microbiology protocols, investigations, reports, and technical assessments.
- Experience with microbiological method verification, method suitability, and/or validation activities.
- Demonstrated ability to provide technical leadership, training, mentoring, and oversight of microbiology personnel.
- Working knowledge of GMP requirements, aseptic practices, contamination control principles, data integrity, and applicable microbiology standards and compendial requirements.
- Strong organizational, analytical, and problem-solving skills with the ability to prioritize and manage multiple complex activities simultaneously.
- Ability to evaluate microbiological data, identify trends and potential adverse patterns, establish scientifically sound conclusions, and make risk-based decisions.
- Excellent written and verbal communication skills with the ability to effectively communicate technical information across functional groups.
- Ability to work independently, exercise sound judgment, and provide effective technical direction in a fast-paced GMP environment.
- Ability to work off-hours, weekends, or extended hours when required to support manufacturing and laboratory operations.
- Ability to wear required cleanroom and personal protective equipment, including full-body gowning, goggles, face shields, protective gloves, and other applicable PPE.
Preferred:
Master's degree in Microbiology, Biology, or a related scientific discipline.
- 5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, cell therapy, or other similarly regulated environment.
- Previous experience in a lead, senior technician, supervisory, or technical leadership role.
- Experience supporting cell therapy or aseptic manufacturing operations.
- Experience with contamination control strategy development and implementation.
- Experience with environmental monitoring program development, qualification, trending, and data analysis.
Schedule- Monday through Friday
- 1st shift
- Occasional Weekends and Overtime Required
Travel RequirementsLocation- This is a 100% onsite, laboratory-based position located at the Durham, NC site.
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