Associate III, Quality Control
- Research Triangle Park, NC
- Department: Quality
- Region: US
About This Role
Biogen’s QC Reference Standards and Qualified Materials (RSQM) group is responsible for the preparation, qualification, and management of reference standards, controls, critical assay reagents, and cells used in analytical methods for Biologics, Small Molecules, ASO, and Gene Therapy programs. The Associate III position is responsible for coordinating reference standard qualification initiatives/projects for ASO and small molecule programs, ensuring all work adheres to cGMP and regulatory regulations. This role requires technical ability to evaluate qualification results and appropriately document results in a technical report. This role reports into the RSQM manager and is cross-functional with stakeholders in QC and development laboratories, Analytical Technology, Global Stability, Regulatory, and Product Development Quality.
What You’ll Do
- Manage preparation, qualification, and inventory for assigned reference standards or qualified materials
- Author and review technical qualification protocols, reports, and change control requests to support the qualification of reference standards
- Coordinate qualification testing, in collaboration with the laboratory operations and Analytical Technology/Development groups
- Participate effectively in a membership role for site cross-functional teams as a representative of the QC RSQM group
- Ship materials to international partners, CLOs, and Ministry of Health laboratories to enable uninterrupted supply of products to patients
Who You Are
Our ideal candidate is detail oriented, enjoys problem solving, and excels at individual responsibilities within the team environment. This position will provide the opportunity to collaborate and innovate within a group who is passionate about transforming patient lives worldwide.
- Ph.D 0-2+ / M.S. 3+ / B.S. 5+ years in comparable role
- Laboratory experience in Bioassay and/or Chemistry
- Background in one or more biopharma/pharma areas including Biologics, Small Molecules or ASO
- Knowledge of chemical analytical methods and/or bioassay methods
- Excels in technical writing, communication, and project management
- A collaborative work ethic
- Works independently
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.