Principal Research Associate, Quality Control Analytical

$85,000 - $100,000/Yr

Neogene Therapeutics - Santa Monica, CA

Full-time - Mid Level

Santa Monica, CA

About the position

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. 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 discussion, 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.

Requirements

• BS or MS in biological sciences or a related field is required.
• 4+ years of relevant experience in Pharmaceutical or Biotechnology industry.
• Flexibility of occasionally working in weekend or holidays to support lot release testing.
• Demonstrated ability to take ownership, initiative, and self-accountability.
• Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
• Experience in Cell or Gene Therapy.
• Well versed in various analytical techniques 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.