QC External Lab Coordinator

Regeneron; City of Rensselaer (NY); On-site; USD 34,000 - 54,000; Full time

Benefits offered by this job

Health and wellness programs

Stock for employees

Job summary

Regeneron is seeking a QC External Lab Coordinator in Rensselaer, NY. You will serve as the operational liaison between Contract Testing Laboratories and internal teams, leading cross-functional meetings, tracking performance, and ensuring sample integrity via LIMS.

The role requires a scientific bachelor's degree and familiarity with cGMP; some on-call duties may be needed. Work is on-site with a typical 1st shift schedule, 8:00am-4:30pm, Monday to Friday.

Qualifications

• Bachelor's degree in a scientific field such as Biology, Chemistry, Microbiology, or related field.
• Experience with cGMP regulations is preferred.
• Ability to work on-call during off-hours may be required.

Responsibilities

• Serve as the primary liaison between CTLs and internal Regeneron partners.
• Lead cross-functional meetings to set timelines, discuss issues, and drive resolution.
• Monitor CTL performance metrics and coordinate mitigation plans.
• Review sample inventory in the LIMS and ensure sample integrity.
• Coordinate with SMEs to troubleshoot issues and identify root causes.
• Arrange on-time shipment of samples to contract labs and manage data entry.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate CAPAs and Change Controls per site procedures.
• Write and update SOPs and manage workflows in the document system.
• Ensure compliance with regulatory requirements and company SOPs.
• Identify and implement process improvements and lean initiatives.

Skills

cGMP knowledge

Education

Bachelor's degree in a scientific field

Job description

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.

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.

We are committed to building a workplace with an inclusive culture. 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.

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. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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.

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.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (hourly)

$25.24 - $39.47