Analyst I, Quality Control

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.

Quality Control Analyst I will primarily be responsible for supporting late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. As part of the Quality operations, you will initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices.

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.

• Actively participates in fostering a positive, collaborative work culture.
• Authoring and revision of standard operating procedures, test methods, protocols, and reports
• Participate in executing raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
• Testing of material utilizing methods such as pH, Osmolality, Appearance, cell culture, bacterial endotoxin, dPCR, ELISA, and other assays used for release and characterization of products.
• Data analysis and review
• Initiate and participate in laboratory investigations, including deviations and out-of-specifications.
• Perform equipment calibrations and analysis of cell viability.
• Participate in the execution of method and equipment troubleshooting and optimization.
• Maintain documentation in accordance with GDP.
• Other duties as assigned.
  
  

Qualifications

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

• B.S. degree in science or a life science-related field of study
• Experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory, is preferred.
• Experience with the following instrumentation: Flow Cytometer (i.e., NC-200), Cell Counter (i.e., NC-200), Hematology Analyzer, Ella
• Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)
• An equivalent combination of education and experience may be considered.
• Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)
• Involvement in continuous improvement initiatives and laboratory investigations
• Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable.
• Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)
• Proficiency in Microsoft Office suite applications.
• Detail-oriented and highly motivated with excellent written and verbal communication skills required.
• 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.
  
  

Physical Demands

• Adjusting or moving objects weighing up to 25lbs
  
  

Travel Requirements

• 10%
  
  

Location

• This is a site-based position located in Durham, NC , and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.
  
  

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.