Specialist, Quality Control Analytical

Position Summary

We are looking for someone with 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, complete 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-hour.

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.

Education and Experience

• 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $76,702 to $115,053. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.