Principal Research Associate, Quality Control Analytical

Position Summary

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We are looking for someone with a cell therapy quality control background to join our Quality Control (QC) team. You will contribute to the advancement of our product pipeline by performing QC analytical method qualification, completing sample analysis, and other assigned tasks.

You will also independently organize and present results and conclusions. You will ensure that the QC Analytical laboratory is operating as expected.

This role may provide occasional technical and supervisory oversight on weekends and off-hours.

Responsibilities

• Perform flow cytometry, ELISA, cellular cytotoxicity, qPCR, and other analytical assays to promote the release testing and stability monitoring of cell therapy products and in-process samples.
• Support analytical method development, qualification, and technical transfer from Analytical Development.
• Support routine analytical activities; occasionally act as a subject matter expert in technical discussions, document review, and investigation.
• Prepare departmental SOPs, technical documents, undertake investigations, review and approvals e.g. OOS, Change Controls, Deviations.
• Author and review analytical test results, technical and regulatory documents including analytical study data summaries and reports, analytical method qualification protocols and reports, standard operating procedures (SOP).
• Perform other tasks as requested by supervisor / manager to support Quality.

Education and Experience

• BS or MS in biological sciences or a related field is required.
• 4+ years of relevant experience in the Pharmaceutical or Biotechnology industry.
• Flexibility of occasionally working on weekends or holidays to support lot release testing.
• Demonstrated ability to take ownership, initiative, and self-accountability.
• Knowledge of cell culture techniques and proficiency in MS Word, Excel, PowerPoint, and other applications.
• Experience in Cell or Gene Therapy.
• Well versed in various analytical techniques including Flow cytometry, qPCR, dPCR, cell-based potency, and / or ELISA experience.

Benefits

• Short-term incentive bonus opportunity.
• Equity-based long-term incentive program.
• 401(k) plan.
• Paid vacation and holidays; paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

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