Immunomedics, Inc.

Quality Control Bioanalytical Scientist

US-NJ-Morris Plains
1 week ago
Job ID
2017-1044
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

We are seeking a QC Bioanalytical Scientist is responsible for routine performance of ELISA-based and cell-based potency assays for release and stability of commercial drug substance and drug product. This position includes responsibility for validation and technical transfer of test methods, including the preparation of validation protocols and reports.

Responsibilities

  • Works in a cGMP QC laboratory setting. Responsible for cell-based potency and receptor binding assays on drug product and drug substance. Ensures timely delivery of test results to meet deadlines for delivery of accurate, verified release, and stability data.
  • Accountable for maintenance of and documenting the performance of cell cultures for performance of cell-based potency assays.
  • Performs timely and accurate review of laboratory results, proactively identifies and reports trends or suspect results, and thoroughly investigates and documents laboratory events and investigations.
  • Effectively participates in the validation and technical transfer of analytical methods in compliance with FDA and ICH guidelines. Authors, reviews, and approves analytical methods, validation protocols, and technical reports.
  • Ensures that laboratory equipment is qualified, maintains and appropriately documents use of equipment within the QC laboratory, and ensures a state of inspection readiness.
  • Provides subject matter expertise regarding the current format and analysis of bioassay data, prepares and presents technical data to management, and trains and mentors laboratory staff.

Qualifications

  • Bachelor's degree in biology or related discipline and 5 to 7 years of experience or advanced degree and 3 to 5 years (preferred) in a Biopharmaceutical and/or Biotechnology environment; or equivalent combination of education and experience.
  • Prior cGMP/GLP training and experience working in a cGMP/GLP environment required.
  • Extensive knowledge and proficiency with cell biology, biochemical, and molecular biology methods and techniques.
  • Experience with statistical analysis and ability to prepare analytical reports, which include evaluation of trends.
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Must be able to work in a team environment and perform job responsibilities under minimal supervision.
  • Must have familiarity with FDA and ICH guidelines and be able to follow SOPs and cGMP guidelines.
  • Must be proficient with MS Office applications.

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