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About the Role

This role utilizes and applies 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.

Responsibilities

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

Requirements

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.

Skills

NGS
Virology
Assay lifecycle management
Method development
Method transfer
Method validation
Product sample-matrix validation
Investigations
Test specification management
Standard procedure creation/revision
Continuous improvement
cGMP
LIMS
Regulatory Sciences
External Manufacturing
Molecular biology assays
Troubleshooting
Compliance
Safety
qPCR
PCR testing

Location

East Greenbush, New York

Work Type

On-site
1st shift

Experience Level

6+ years of experience or equivalent combination of education and experience

Education Level

BS/BA in a Life Sciences 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

We are committed to building a workplace with an inclusive culture.
Regeneron offers a competitive and comprehensive total rewards package.
We believe 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.