QC External Lab Coordinator

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 35,000 - 54,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to manage liaison with external testing labs and internal teams. You will oversee project timelines, issue resolution, and data integrity across QC, QA, Regulatory, Manufacturing, and Supply Chain.

The role emphasizes cGMP compliance, documentation, process improvements, and CAPA initiation while ensuring timely shipment of samples and data exchange with CTLs.

Qualifications

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related).
• 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 the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners (QC, QA, Regulatory Affairs, Manufacturing, Supply Chain).
• Lead cross-functional meetings with CTLs and internal partners to establish project timelines, discuss issues, supervise progress, and drive resolution.
• Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; identify risks and implement mitigations.
• Use a LIMS sample tracking system to review inventory against samples sent/received by external labs to ensure 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 of test data.
• Provide technical support for invalid assays, deviations, and OOS/OOT investigations.

Education

Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related)

Job description

Team: Industrial Operations & Product Supply

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:

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.

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.

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. If you have any questions, please speak with your recruiter.

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

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