Microbiology Analyst III, Quality Control

Kincell is a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing.

Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs.

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

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

This 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. 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 accommodations 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.

• Perform environmental monitoring (air, surface, compressed gas, and personnel) of the cleanrooms and laboratory to support GMP manufacturing to include off hours and weekends when required.
• Manage and schedule contract testing laboratories for environmental monitoring and testing.
• Perform critical utility monitoring.
• Perform QC testing on raw materials and in-process products. Generate records in compliance with GMP requirements.
• Coordinate QC testing with external labs including sample submission and final reports.
• Proper media, buffer and reagent preparation.
• Perform growth promotion of microbiological media.
• Operate and maintain the lab in a neat and orderly way – following procedures and completing/ maintaining appropriate records.
• Thorough and focused execution of laboratory experiments and assays (bioburden, endotoxin, gram stain, plate reading, etc.).
• Perform laboratory equipment maintenance and calibration as needed.
• Perform data analysis and trending, report generation, and conclusions.
• Perform environmental monitoring and assay related investigations.
• Assist with qualification and validation of equipment, processes, and analytical methods, including protocol development and execution.
• Comply with all company policies, procedures, and SOPs.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

• Strong organizational and analytical skills.
• Strong independent work ethic.
• Able to prioritize and manage through multiple complex processes/projects.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Detail-oriented and highly motivated with excellent written and verbal communication skills.
• Ability to work independently and stay on task in a fast-paced environment without direct supervision.
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
• Able to wear cleanroom/protective gowning and equipment, including but not limited to full body gowning, goggles, face shields, and protective gloves.

Required:

• Bachelor’s Degree in a scientific discipline with 2 years related experience OR a minimum of 5 years related experience.
• Proficiency in Microsoft Office suite applications
  An equivalent combination of education and experience may be considered.

Preferred:

• Environmental monitoring experience in a cleanroom setting is required.

Travel Requirements

• None

Physical Requirements

• Lift/Carry up to 40 pounds
• Use of Safety Shoes
• Use of a Face Mask

Location

• This is a laboratory-based position located at the Durham, NC site.

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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.