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Clinical-Scientific - Bench Scientist Bench Scientist

$108k+
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Full-time
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POSITION SUMMARY
Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document.
The position will support the Client Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability. Key responsibilities are performing GMP tasks associated with maintaining compliant chain of custody and sample management of QC and Stablity samples.
POSITION RESPONSIBILITIES
In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
  • Supports the sample management process for QC (pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc)
  • Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)
  • Responsible for following Client and current GMPs and GDPs in adherence with regulatory requirements and Client QMS
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
  • Vaccine and Gene Therapy manufacturing
  • Warehouse
  • Quality Control Labs (Bioanalytical, Chemistry, Microbiology, Method Validation and Stability)
  • Quality Control Support (Instrumentation, Standards and Controls, Lab Support)

EDUCATION AND EXPERIENCE
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
  • 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
  • A BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry is preferred; however, other appropriate combinations of education and/or experience in the biotech or pharmaceutical industry are suitable.
  • Understanding of laboratory practices and processes

TECHNICAL SKILLS REQUIREMENTS
Indicate the technical skills required and/or preferred, as applicable.
  • Previous experience with an electronic LIMS system (preferred)
  • Previous experience with sample chain of custody (preferred)
  • Previous experience handling API, Raw Material, Drug Substance or Product intermediates (preferred)

Last updated on Nov 10, 2023

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