Associate QC Tech Resources Scientist

Regeneron Pharmaceuticals, Inc.

City of Rensselaer (NY)

On-site

USD 62,000 - 92,000

Full time

5 days ago
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Benefits offered by this job

Annual bonuses
Equity awards
Pension benefits
401(k)
Health & wellness
Fitness centers
Insurance benefits
Paid time off
Family support

Job summary

Regeneron Pharmaceuticals, Inc. seeks a specialist to support method lifecycle management within Quality Control (QC).

You will apply scientific knowledge to perform and review assay characterization, transfer, validation, and investigation, acting as a SME to guide release, stability, in-process testing, and assay development. You will collaborate with Analytical Sciences to integrate methods into QC, monitor performance across sites, and coordinate post-transfer investigations, ensuring timely

Qualifications

  • Requires a BS/BA in Chemistry, Biochemistry, Biology or related field.
  • 2+ years of experience for intermediate role or 5+ years for senior; equivalent education/experience accepted.
  • Ability to collaborate across functions and coordinate multi-site activities.

Responsibilities

  • Collaborate with Analytical Sciences to integrate methods into QC Commercial, evaluating and selecting suitable methods prior to process validation.
  • Monitor and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed.
  • Liaise with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management.
  • Monitor method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites.
  • Coordinate post-transfer investigations and multi-site trending, escalating issues to management when necessary.
  • Drive process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers.
  • Develop and draft new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports.
  • Participate in training programs for QC personnel, ensuring all activities align with project timelines and deliverables.

Education

BS/BA in Chemistry, Biochemistry, Biology or related field
BS/BA in Chemistry, Biochemistry, Biology with 2+ years experience
BS/BA in Chemistry, Biochemistry, Biology with 5+ years experience

Job description

Summary

Supports method lifecycle management within Quality Control (QC). This position utilizes and applies scientific knowledge and techniques to perform and review assay characterization, optimization, transfer, validation, and investigation. As a subject matter expert (SME), the role provides guidance, technical advice, and supervision for release, stability, in-process testing, and assay development.

Essential Duties and Responsibilities
  • Collaborate with Analytical Sciences (AS) to integrate methods into QC Commercial, evaluating and selecting suitable methods prior to process validation.
  • Monitor and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed.
  • Liaise with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management.
  • Monitor method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites.
  • Coordinate post-transfer investigations and multi-site trending, escalating issues to management when necessary.
  • Drive process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers.
  • Develop and draft new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports.
  • Participate in training programs for QC personnel, ensuring all activities align with project timelines and deliverables.
Education and Experience
  • Assoc: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field, or equivalent combination of education and experience.
  • Int: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field and 2+ years of experience or equivalent combination of education and experience.
  • Sr: Requires a BS/BA in Chemistry, Biochemistry, Biology or related field and 5+ years of experience or equivalent combination of education and experience.
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
  • and family support benefits
Salary Range (annually)

$62,355.00 - $92,400.00

Equal Opportunity Statement

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.

Additional Details

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.

On-site Requirement

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

Background Checks

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.

Canada Posting

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

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