Microbiology Technician Lead, Quality Control - Temporary Contract

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch.  Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

For more information, please visit our website at www.kincellbio.com.

Kincell is seeking a highly motivated Microbiology Technician Lead who will be a key contributor to a dynamic and collaborative Quality Control team.

This Contract position will support the day-to-day activities of the manufacturing and quality control group by performing lot related and routine environmental monitoring of the cleanrooms, microbial assay testing, maintenance of laboratory supplies, routine data trending, and coordination of samples to outside testing laboratories, and scheduling and managing technicians. Personnel will work in concert with and assist the manufacturing department and play a critical role in ensuring environmental control of the aseptic manufacturing facility.

Essential Duties and Responsibilities

Reasonable 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 technical support and lead-level guidance for microbiology laboratory and environmental monitoring activities supporting GMP manufacturing operations.
• Coordinate daily microbiology workload and assist in prioritizing environmental monitoring, QC testing, investigations, and other laboratory activities to ensure timely completion.
• Serve as a key technical resource and primary backup for microbiology and QC testing activities, maintaining proficiency in applicable microbiological and QC methods, including sterility, endotoxin, growth promotion, environmental monitoring, osmolality, pH and other applicable assays.
• Perform microbiological testing to support routine laboratory operations, manufacturing schedules, investigations, staffing requirements, and off-hours/weekend coverage as needed.
• Perform environmental monitoring activities, including viable air, surface, personnel, compressed gas, and other applicable monitoring within classified cleanrooms and laboratory areas.
• Perform sterility testing, method verification, and method suitability activities, including testing using the BacT/ALERT 3D System.
• Perform routine operation, cleaning, maintenance, and troubleshooting of microbiology laboratory equipment and coordinate calibration and servicing as required.
• Assist with microbiology investigations, including environmental monitoring excursions, atypical results, out-of-specification results, and other microbiological events.
• Assist with root cause analysis, impact assessments, corrective actions, and effectiveness evaluations associated with microbiological investigations.
• Review microbiology records and analytical data for accuracy, completeness, compliance with procedures, and adherence to data integrity requirements.
• Serve as a technical resource to microbiology personnel and assist with troubleshooting laboratory methods, equipment, and testing activities.
• Assist in maintaining the microbiology laboratory in a clean, orderly, compliant, and inspection-ready condition.
• Collaborate with Quality Assurance, Manufacturing, Engineering, Validation, and other departments to support manufacturing operations, investigations, contamination control, and laboratory activities.
• Ensure all activities are performed in accordance with company policies, procedures, SOPs, GMP requirements, applicable regulatory expectations, and data integrity principles.

Qualifications

The 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 2 years of relevant microbiology laboratory experience in a GMP-regulated environment.
• Demonstrated experience with environmental monitoring in classified cleanroom environments.
• Hands-on experience with aseptic gowning and working within classified cleanroom environments.
• Demonstrated proficiency in microbiological testing, including sterility, bacterial endotoxin, microbial enumeration, subculture techniques, environmental monitoring, osmolality, pH, etc.
• Demonstrated ability to provide technical leadership, mentoring, or oversight of microbiology personnel.
• Working knowledge of GMP requirements, aseptic practices, contamination control principles, data integrity, and applicable microbiology standards and compendial requirements.
• Proficiency with Microsoft Office applications.
• Strong organizational, analytical, and problem-solving skills with the ability to prioritize and manage multiple complex activities simultaneously.
• Ability to evaluate data, identify trends, establish scientifically sound conclusions, and make risk-based decisions.
• Excellent written and verbal communication skills.
• Ability to work independently, exercise sound judgment, and provide effective technical direction in a fast-paced GMP environment.
• Detail-oriented, highly motivated, and committed to maintaining high standards of laboratory quality, compliance, and data integrity.
• Ability to wear required cleanroom and personal protective equipment, including full-body gowning, goggles, face shields, protective gloves, and other applicable PPE for extended periods of time.

Preferred:

• Experience with automated microbial detection systems, such as the BacT/ALERT 3D System.
• Experience with microbiology investigations, environmental monitoring excursions, atypical results, and out-of-specification events.

Schedule

• Monday through Friday
• 2^nd shift
• Occasional Weekends and Overtime Required
• Training will take place on 1^st shift

Travel Requirements

• None

Location

• This is a 100% laboratory-based position located at the Gainesville, FL site.

#LI-Onsite

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.