Analyst II, Quality Control

oxfordbiom•Durham, NC

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Analyst II to join our Quality Control team. In this role, you will interface with multiple Quality Control functions in support of method qualification, transfer, and validation activities, playing a key part in advancing our mission and making a real difference.

Requirements

BS with 3+ years in a biotechnology discipline
3+ years of experience in a cGMP/GxP environment is preferred
Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA and UPLC methods.

Responsibilities

Perform cGMP analytical testing (Cell based Assays, flow cytometry, qPCR, ddPCR, ELISAs, and UPLC)
Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
Author, review, and/or approve SOPs/policies and technical reports with general guidance
Support laboratory deviations and investigations (IA, OOS, AR).
Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
Execute phase-appropriate test method validation protocols as needed