Scientist - Biologics Development

2 weeks ago


Frederick, Maryland, United States Medix™ Full time

RESPONSIBILITIES:

  • Develop and optimize cell-based assays to characterize biologics.
  • Design and conduct laboratory experiments to validate analytical methods for biologics using immunoassays and cell-based assays.
  • Author and review method development reports, method qualification study protocols, and qualification study reports.
  • Perform sample testing, analyze data, interpret results, and report findings in formats such as electronic laboratory notebooks (ELNs), formal reports, and presentations.
  • Author and review standard operating procedures (SOPs) for test method procedures and laboratory equipment operation and maintenance.
  • Ensure proper qualification, calibration, and maintenance of laboratory equipment according to established schedules.
  • Adhere to current Good Manufacturing Practice (cGMP) requirements and maintain compliance with standard operating procedures to uphold quality standards.
  • Undertake additional duties and responsibilities as needed to support laboratory objectives.
  • Working knowledge of statistical analysis software is a plus.

QUALIFICATIONS:

  • PhD, MS, or BS degree in Biochemistry, Pharmaceutical Analysis, Biotechnology, or Biology.
  • BS degree with 5+ years, MS with 3+ years, or PhD with 1+ years of industry laboratory experience.
  • Hands-on experience with immunoassays and cell-based assays.
  • Experience in developing and qualifying analytical methods for biologics is advantageous.
  • Strong multi-tasking abilities, effective time management skills, and excellent organizational capabilities.
  • Ability to work collaboratively in a team environment, with meticulous attention to detail and exceptional verbal and written communication skills.


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