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About the Role

Regeneron is seeking a Quality Control Microbiology Lab Operations Specialist to join the QC team. This role involves performing microbiological assays for clean room, utility, raw material, and product testing in compliance with SOPs and cGMP/FDA regulations. The specialist will act as a technical resource for microbiological methods, laboratory processes, and compliance, supporting operational excellence within the QC Microbiology organization.

Responsibilities

Serve as a technical resource and Subject Matter Expert (SME) for QC Microbiology laboratory operations, microbiological methods, and testing programs.
Evaluate, implement, and support new or revised microbiological methods, laboratory procedures, equipment, software applications, and reporting tools.
Lead and support laboratory studies, protocols, troubleshooting efforts, and technical assessments to improve testing effectiveness and operational efficiency.
Represent QC Microbiology on cross-functional teams and project initiatives.
Lead and support complex laboratory investigations, deviations, non-conformances, and root cause analyses.
Perform data gathering, trend analysis, and technical assessments to support investigations and business decisions.
Initiate, execute, and close quality system records including Change Controls, CAPAs, deviations, and document revisions.
Ensure investigations and quality system activities are completed in compliance with cGMP requirements, company procedures, and regulatory expectations.
Author, revise, and review SOPs, technical reports, protocols, risk assessments, and other controlled documents.
Facilitate inspection readiness activities and participate in internal audits, regulatory inspections, and client audits.
Monitor regulatory and technical updates and incorporate applicable changes into laboratory procedures and practices.
Ensure laboratory activities, documentation, and data integrity practices remain compliant with applicable regulations and industry standards.
Monitor and analyze laboratory performance metrics and Key Performance Indicators (KPIs).
Identify and implement process improvements to enhance efficiency, compliance, data quality, and laboratory performance.
Support strategic initiatives aimed at improving microbiology testing, sampling programs, and laboratory operations.
Collaborate with internal stakeholders and external partners to resolve technical and operational challenges.

Requirements

Advanced knowledge of pharmaceutical microbiology principles and practices.
Advanced knowledge of microbiological testing methods including endotoxin, sterility, bioburden, environmental monitoring, utility monitoring, and raw material testing.
Understanding of cGMP regulations, data integrity requirements, and laboratory compliance expectations.
Ability to navigate and interpret regulatory guidance documents and compendial requirements.
Experience conducting laboratory investigations and root cause analyses.
Knowledge of Change Control, CAPA, deviation management, and quality systems.
Strong analytical, technical writing, and problem-solving skills.
BS/BA in Biology, Microbiology or related field, and 2+ years of relevant experience.
Experience with electronic quality management systems and laboratory software applications.
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
Working knowledge of Laboratory Information Management Systems (LIMS), Learning Management Systems (LMS), and deviation management systems.
Experience supporting regulatory inspections and audit readiness activities.
Experience in biologics, sterile manufacturing, or gene therapy environments.
Experience implementing new laboratory methods, instrumentation, software systems, or process improvements.
Demonstrated leadership in cross-functional project execution and continuous improvement initiatives.

Skills

Microbiology
cGMP
FDA regulation
SOPs
Technical writing
Problem-solving
Data analysis
Quality systems
Change Control
CAPA
Deviation management
Microsoft Office Suite
LIMS
LMS

Location

Rensselaer, New York, United States

Work Type

Onsite
Full-time

Experience Level

2+ years of relevant experience

Education Level

BS/BA in Biology, Microbiology or related field

Salary/Compensations

$67,400.00 - $110,000.00

Benefits

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
Family support benefits

About the Company

Regeneron is committed to building a workplace with an inclusive culture.
Regeneron believes we do our best work when we are together.
Many roles are required to be performed on-site.

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, 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.