Analytical Technology & Operations Specialist

Regeneron Pharmaceuticals, Inc (USA); City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY, is hiring multiple Quality Analytical Technology & Operations Specialists to join the Quality Control team at our new automated drug substance facility.

The role emphasizes data integrity, lab system integration, and qualification testing across 1st shift with domestic travel. Candidates should have a BS/BA in Engineering, Chemistry, or Life Sciences, with 0–5+ years depending on level.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; substitution allowed for experience.
• 0–2+ years for Assoc Analyst role; 2+ years for Analyst; 5+ years for Sr. Analyst; level based on experience.
• Familiarity with data integrity (ALCOA+), 21 CFR Part 11, Annex 11, and GxP requirements.
• Exposure to laboratory system integration CDS, LIMS, instrument interfacing, or data acquisition preferred.

Responsibilities

• Gather inputs to assay-to-space model: equipment lists, footprint measurements.
• Document User Requirement Specification content; note integration details.
• Maintain integration documentation for lab systems connecting to lab bus; flag gaps.
• Document material, sample and personnel flow from receipt to waste.
• Support risk assessments by collecting evidence and organizing findings.
• Prepare materials and impact docs for design reviews and VE changes.
• Coordinate instrument delivery, installation, and FAT/SAT activities.
• Execute qualification protocols and acceptance testing for lab functionality.
• Support LIMS configuration and digital lab integration tasks.
• Draft and revise SOPs for access, sample handling, and waste management.
• Assist in dry runs of sample-to-result path and engineering runs.
• Provide post-handover support to QC testing; triage issues and support change control.

Skills

Analytical thinking

Documentation

Quality systems

Data integrity

Collaboration

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

LIMS

CDS

Lab instrumentation

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Analytical Technology & Operations Specialist to join our Quality Control team at our new highly automated drug substance manufacturing facility in Saratoga Springs.

Location: Rensselaer, New York, United States. Work model: 1st, Monday- Friday, 8am-4:30pm. Travel: 50% domestic.

Discover your role:

• Gather and document inputs to the assay-to-space model for the assigned area — equipment lists, footprint measurements, bench linear feet.
• Support development of User Requirement Specification content by documenting equipment and network/instrument integration details; escalate integration decisions.
• Help maintain integration documentation for laboratory systems connecting to the lab bus, flagging any data integrity or control gaps.
• Document material, sample, and personnel flow for the assigned area — receipt through login, preparation, analysis, retain, and waste — based on approved process maps.
• Support data integrity risk and gap assessment activities by collecting evidence, completing checklists, and organizing findings for the Senior Specialist’s review.
• Prepare supporting materials and impact documentation for design reviews and proposed value-engineering changes.
• Coordinate day-to-day logistics for instrument delivery, installation, and FAT/SAT activities against the first test-date schedule.
• Execute qualification protocols and pre-defined acceptance criteria testing for lab critical functionality.
• Support LIMS configuration and laboratory digital integration tasks.
• Assist in maintaining integration requirement documentation for lab bus–connected systems, escalating any design-versus-installation discrepancies.
• Draft and revise SOPs for the assigned space — access and gowning, sample receipt and handling, instrument operation, cleaning and sanitization, waste, cold chain, and retain management.
• Participate in and help execute dry runs of the sample-to-result path, and support engineering runs for the assigned area.
• Provide day-to-day post-handover support to the site QC testing team - triaging routine issues and helping execute change control and corrective actions, escalating complex or ambiguous issues to the Senior Specialist.

This role requires:

• BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education.
• Assoc Analytical Technology & Operations Specialist: 0-2+ years of relevant experience.
• Analytical Technology & Operations Specialist: 2+ years of relevant experience.
• Sr. Analytical Technology & Operations Specialist: 5+ years of relevant experience. Level will be determined based on experience.
• Familiarity with data integrity principles (ALCOA+), 21 CFR Part 11, Annex 11, and GxP requirements, with a developing ability to apply them under guidance.
• Exposure to laboratory system integration CDS, LIMS, instrument interfacing, or networked data acquisition is preferred.
• Exposure to a laboratory build, relocation, fit-out, or instrument implementation project is preferred.

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.

Salary Range (annually) $62,355.00 - $131,300.00.

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.

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.