QC Virology Scientist

Quality Control Virology Scientist

We are looking for a Quality Control Virology Scientist. This role will utilize and apply scientific knowledge and techniques to support assay lifecycle management within QC Virology. As a subject matter expert (SME), the individual will be responsible for new virus and mycoplasma detection method development or improvement, method transfer, method validation, or product sample-matrix validation, investigations, test specification management, standard procedure creation or revision, and continuous improvement project management with a focus on developing next-generation sequencing (NGS) technologies in a cGMP-compliant manner.

When & Where:

Monday-Friday 1st shift

East Greenbush, New York

Discover your role:

• Performs NGS testing in a cGMP environment
• Utilizes a Laboratory Inventory Management System (LIMS) to document method execution progress and results
• Facilitates the transition of methods from QC Virology Technology to QC Virology Operations teams, including evaluating and implementing appropriate methods and reagents
• Monitors and analyzes method performance within the QC Virology Operations lab, addressing issues with subject matter expertise, as needed
• Works directly with Regulatory Sciences, External Manufacturing and collaborators; communicates timelines for method validation, method transfers and product-specific qualifications to managers in QC Virology Operations
• Communicates method updates to partners and tracks progress of updates
• Participates in and coordinates post-transfer/validation/qualification investigations between contract laboratory sites, collaborative partners, and QC Virology Operations
• Tracks team activities and timelines to ensure that the deliverables within the project plans are met and on time
• Continuously drives to improve processes to enhance efficiency/performance
• Performs and/or coordinates method validation and/or product-specific qualification for the QC Virology Operations team
• Implements new assays and associated test procedures for QC Virology Operations
• Performs and/or coordinates assay transfers internally and externally
• Authors and/or coordinates technical document preparation (including, but not limited to: technical justification documents, Assay Validation Protocols, Assay Validation Reports, Product Qualification Reports)
• Participates in training programs for QC Virology personnel
• Maintains virus and mycoplasma detection assays, including protocol writing and reporting
• Evaluates and implements new technologies in cGMP settings
• Serves as SME for molecular biology assays (i.e., NGS and PCR testing) and applies troubleshooting methods
• Ensures compliance and safety in laboratory environments

This role requires:

• BS/BA in a Life Sciences field and 6+ years of experience or equivalent combination of education and experience.
• Experience with molecular techniques (i.e., qPCR, NGS), method development, method validation, and transfer activities preferred
• Level will be determined based on experience and qualifications.

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.

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

Salary Range (annually): $67,400.00 - $