Scientist, Quality Control

Rockland•Pottstown, PA

About The Position

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.

Requirements

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
Command of English language—written and oral
Ability to read and understand SOPs
Bachelor’s degree in biochemistry, pharmacology, molecular biology, cancer biology, or related field or associate degree in similar field with laboratory experience

Nice To Haves

Experience with SoftMaxPro is desired, but not required.
Knowledge of QSR/cGMP guidelines or other documentation processes is a plus

Responsibilities

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