Scientist I- Immunoassay

4 weeks ago

Malvern, United States Resolian Full time

Performs and leads complex lab work, sample analysis, validation, and method development with limited supervision.


Responsibilities

  • Prepare reagents, standards, and control samples
  • Analyze samples using various techniques specific to department
  • Perform complex method development with limited supervision
  • Perform method validation or qualification
  • Operate analytical equipment
  • Lead troubleshooting activities; assays and equipment
  • Maintain analytical equipment
  • Review, evaluate, and interpret data results
  • Draft and present posters/presentations
  • Train and mentor lower level Scientists
  • Collaborate with clients and vendors
  • Ensure lab area is clean and inspection ready at all times
  • Remove lab waste
  • Record tasks in accordance with Good Documentation Practices (GDP)
  • Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11
  • Follow applicable SOPs and procedural documents
  • Other tasks as assigned


Education, Experience & Skills Required

  • BA/BS or higher with 7-8 years lab experience; all experiences will be evaluated
  • Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
  • Able to independently perform complex lab work
  • Able to work in a regulated environment
  • Able to work effectively and contribute within a team
  • Able to work with computer systems
  • Able to document clearly
  • Knowledge of and experience in a regulatory environment

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