Quality Control Analyst, Bioassay
NKGen Biotech is seeking a Quality Control Analyst (Bioassay team) to perform bioanalytical testing in a cGMP environment.
- Conduct biological analyses of raw materials, in-process and final cell product to support manufacturing, validation, process development and stability studies in a GMP environment.
- Perform bioanalytical cell-based assays with precise skills and understanding scientific principles.
- Perform daily task such as Cell culture, flow cytometry, potency test, ELISA, qPCR, and visual inspection.
- Complete testing in an appropriate and timely manner.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
- Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations, and method development projects.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Actively oversee laboratory supply inventory and manage purchasing for conducting routine tests.
- Work closely with Facilities and Engineering to coordinate equipment maintenance and calibrations.
- Provide mentorship to junior staff and supporting new employee onboarding.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Bachelor’s Degree in Biology, Immunology, or other Life Science with 5+ yr experience
- Master’s degree in Biology, Immunology, or other Life Science with 3+ yr experience
- Extensive hands-on experience of Cell culture, Flow cytometry, ELISAs, qPCR, DNA isolation, and other applicable methods to the testing of biopharmaceuticals.
- Experience in various cell-based assays is preferred.
- Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia, and guidance documents.
- Experience working with Smartsheet a plus.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
- Self-motivated and Comfortable in a fast-paced, start-up environment, while dealing with ambiguity.
- Candidates must be authorized to work in the U.S. and agree to a background check.
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!