QC External Lab Coordinator

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 35,000 - 54,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a QC External Lab Coordinator to manage external testing activities and ensure cGMP compliance. The role interfaces with CTLs, QC, QA, Regulatory, and Supply Chain to drive timelines, data integrity, and issue resolution.

The position requires a scientific degree and familiarity with cGMP; occasional on-call support and on-site work in Rensselaer, NY, with a Monday–Friday schedule on the 1st shift.

Qualifications

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field).
• Experience with cGMP is preferred.
• Occasions where you may be on call during off-hours to support critical shipment or entry of results.
• Level is settled based on qualifications relevant to the role.

Responsibilities

• Serve as primary operational liaison between CTLs and internal partners (QC, QA, Regulatory Affairs, Manufacturing, Supply Chain).
• Lead cross-functional meetings with CTLs and internal partners to set timelines, discuss issues, supervise progress and drive resolution.
• Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; identify risks and mitigate.
• Use a LIMS to review sample inventory against samples sent/received to maintain accuracy and sample integrity.
• Coordinate activities between external laboratories and Regeneron SMEs to troubleshoot issues and identify root causes.
• Coordinate on-time shipment of samples to Contract Testing Labs and receipt/entry of test data.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate and complete CAPAs and Change Controls per site procedures and write/update SOPs as needed.

Skills

Bachelor's degree

On-call readiness

cGMP awareness

Education

Bachelor's degree in scientific field

Tools

LIMS

Job description

Company Overview

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.

Location & Work Model

Location: Rensselaer, New York, United States
Work model: 1st shift | Monday-Friday | 8:00am-4:30pm

Role Responsibilities

• 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.

Requirements

• 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.

Benefits & Culture

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!

Equal Opportunity

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.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Salary Information

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.

Salary Range (hourly) $25.24 - $39.47

Comprehensive Total Rewards Package

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

On-Site Expectations

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Company Profile

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.