Biochemistry Analyst I - CARsgen Therapeutics Corpora
Durham, NC
About the Job
- Responsibilities
- Conduct bench analysis such as cell culture, flow cytometry, cell viability determination, ELISA, and/or qPCR under the guidance of cGMP and internal procedures.
- Participate in QC Bioassay Laboratory operations including the laboratory equipment maintenance, laboratory reagent and inventory management, data review, and training.
- Routinely prepare and maintain cell culture reagents, media and supplies.
- Participate in execution of analytical method qualification and validation studies.
- Initiate deviations and laboratory investigations including invalid assays, deviations, and OOS/OOT.
- Make minor revisions to SOPs and forms for chemistry and biochemistry methods.
- Maintenance and routine care of equipment.
- Review of logbooks and peer review of assay forms.
- Identify and communicate risks to upper management.
- Qualifications
- Bachelor of Science degree in Chemistry, Biochemistry or a related life science.
- Experience in GMP quality control, quality assurance or manufacturing preferred.
- Cell-based Bioassay/ELISA background and/or Immunology background is preferred.
- Understanding of applicable USP, ICH, and Ph Eur standards related to intermediate, release and stability testing is preferred.
- Excellent verbal and written communication skills.
- Some experience troubleshooting analytical equipment and methods preferred.
- Ability and desire to work in a fast-paced, team-oriented environment
Source : CARsgen Therapeutics Corpora
