QC Microbiology Lead - GMP Cell Therapy Lab

Kincell Bio, LLC; North Carolina; On-site; USD 90,000 - 125,000; Full time

Job summary

Kincell Bio is seeking a highly motivated QC Microbiology Supervisor to lead microbiology and environmental monitoring activities supporting GMP manufacturing. You will oversee testing, investigations, and method development, ensuring data integrity and compliance across our Durham NC facility.

The role requires hands-on testing, leadership of microbiology personnel, and collaboration with QA, Manufacturing, and Validation to drive continuous improvement in contamination control and process

Qualifications

• 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 judgement 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.
• Master's degree in Microbiology, Biology or a related scientific discipline.

Responsibilities

• 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, growth promotion, environmental monitoring, and related 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.

Skills

Leadership

GMP knowledge

Analytical thinking

Problem solving

Communication

Time management

Independence

Training & mentoring

Data interpretation

Risk assessment

Education

Bachelor's degree in Microbiology/ Biology or related

Master's degree (preferred)

Tools

BacT/ALERT 3D System

Job description

Kincell Bio is seeking a highly motivated QC Microbiology Supervisor to lead microbiology and environmental monitoring activities supporting GMP manufacturing. You will oversee testing, investigations, and method development, ensuring data integrity and compliance across our Durham NC facility.

The role requires hands-on testing, leadership of microbiology personnel, and collaboration with QA, Manufacturing, and Validation to drive continuous improvement in contamination control and process