Scientist, Quality Control

Responsibilities include:

• Carry out assays for antibody validation of antiserum, in-process material, and finished products


• Timely execution of medium throughput QC testing


• Sample preparation of serum, buffers, and other biological material for QC testing


• Generate QC testing reports and qualification/validation reports according to Standard Operating Procedures (SOPs) and other guidelines


• Engage in method optimization, troubleshooting, and qualification/validation as required


• Make recommendations for optimization and troubleshooting of testing assays


• Validate, document, and manage inventory of raw material (antisera), reagents, and other materials used


• Maintain equipment as required for SOP and good manufacturing practice quality guidelines


• Follow appropriate SOPs and internal documentation requests


• Complete training in additional immunoassays performed by the QC group including ELISA, SDS-PAGE, Western Blot, and Immunoelectrophoresis.


• Perform coagulation and precipitin assays to confirm specific antibody-antigen reactions


• Participate in project team activities and/or departmental initiatives


• Perform other duties as assigned

Qualifications:

• 1+ year of experience in antibody-based assays preferred


• Hands-on experience in performing antibody-based assays such as IEP, Western blotting, immunofluorescence, and ELISA


• Demonstrate clear understanding of antibody biology, immunoassays, and basic laboratory techniques


• Demonstrated ability for project documentation, data analysis, and generation of comprehensive reports


• Must have ability to use MS Word, MS Excel, and other MS Office applications


• Experience with SoftMaxPro is desired, but not required.


• Command of English language—written and oral


• Ability to read and understand SOPs


• Knowledge of QSR/cGMP guidelines or other documentation processes is a plus

Education:

• Bachelor’s degree in biochemistry, pharmacology, molecular biology, cancer biology, or related field or associate degree in similar field with laboratory experience

NOTE: This position can be filled as a Scientist I, II, or III  based on candidate experience.