QC External Lab Coordinator

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are currently looking to fill a Quality Control (QC) External Lab Coordinator position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC External Testing Coordinators supports the daily operations of the QC External Testing group in accordance with Standard Operating Procedures (SOPs) and cGMP regulations.   When & where: • Location: Rensselaer, New York, United States • Work model: 1st shift | Monday-Friday | 8:00am-4:30pm   Discover your role: • Serving as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners, including QC, QA, Regulatory Affairs, Manufacturing, and Supply Chain teams. • Leading cross-functional meetings with CTLs and internal partners to establish project timelines, discuss technical issues, supervise progress, and drive issue resolution. • Monitoring CTL performance metrics, turnaround times, testing capacity, and schedule adherence; growing risks and implementing mitigation plans as appropriate. • Using a sample tracking system (LIMS) to review sample inventory against samples sent and received by external laboratories to resolve accuracy and to maintain sample integrity. • Coordinating activities between external laboratories and Regeneron subject matter experts (SMEs) to troubleshoot issues and identify root causes. • Coordinating on-time shipment of samples to Contract Testing Labs. • Coordinating receipt and entry of test data from Contract Testing Labs. • Providing technical support as needed for invalid assays, deviations, OOS/OOT investigations. • Initiating and completing CAPAs and Change Controls in accordance with site procedures. • Writing new SOPs and updating existing SOPs as needed. • Initiating and handling workflows in the electronic document management system. • Ensuring that all work performed follows required regulatory requirements (e.g. cGMP), company policies, and standard operating procedures (SOPs). • Proactively identifying and implementing process improvements, lean initiatives. • Performing other duties relevant to the position as required.     This role requires: • Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field) • Experience with cGMP is preferred. • Occasions where you may be required to be on call during off-hours (ex. weekends, holiday breaks) to support critical shipment or entry of results. • Level is settled based on qualifications relevant to the role.      Does this sound like you?  Apply now to take your first steps toward living the Regeneron Way!  We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.  We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.  Please contact us to discuss any accommodations you think you may need.