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.
