Biochemistry Analyst I

CARsgen Therapeutics Corpora - Durham, NC

Full-time - Entry Level

Durham, NC

About the position

The Biochemistry Analyst I position is a full-time role based in Durham, NC, focused on conducting various bench analyses and participating in quality control operations within a laboratory setting. The role involves working under cGMP guidelines and internal procedures to ensure the accuracy and reliability of laboratory results, while also maintaining laboratory equipment and managing inventory.

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 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 logbooks and peer review of assay forms.
• Identify and communicate risks to upper management.

Requirements

• 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.

Nice-to-haves

• Experience in GMP quality control, quality assurance or manufacturing.
• Cell-based Bioassay/ELISA background and/or Immunology background.
• Understanding of applicable USP, ICH, and Ph Eur standards related to testing.