Full-Time

Manager QA Validation

Fill Finish

Confirmed live in the last 24 hours

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops biopharmaceuticals for serious diseases

Compensation Overview

$104.3k - $199k/yr

Senior, Expert

Albany, NY, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in Chemistry, Engineering, or Life Sciences
  • Manager: 7+ years of experience
  • Sr. Manager: 8+ years of experience
  • Proven experience may substitute for education requirement
Responsibilities
  • Leads cross-functional teams in developing Validation best practices, standards and guidelines
  • Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables
  • Execution of validation projects and being responsible for Validation projects as well as junior-level staff
  • Performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation results
  • Reviews and approves Validation protocols and summary reports generated by the Validation staff
  • Prepares equipment for qualification studies and implements qualification and validation studies according to approved protocols and SOPs
  • Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
  • Approves various documents relating to area function
  • Provides direction and assigns work to Validations Specialists to meet goals and timings
  • Coordinates prioritization of activities with area management
  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions
  • Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality
  • Participates in regulatory and customer activities
  • Collaborates with functional departments to resolve issues
  • Leads projects and prepares status reports
Desired Qualifications
  • Strong leadership and project management skills
  • Thrive in a quality focused environment
  • Possess a positive, proactive approach to drive projects/tasks to completion
  • Able to mentor and encourage others
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

View

Regeneron Pharmaceuticals develops medicines aimed at treating serious diseases such as cancer, eye diseases, and allergic conditions. The company uses its own technologies and extensive research to create new therapies, often collaborating with academic institutions and other pharmaceutical companies to enhance its efforts. Regeneron stands out from competitors by focusing on strategic partnerships that allow for shared development costs and profits. Its goal is to improve patient outcomes through effective treatments while ensuring compliance with safety and efficacy standards.

Company Size

10,001+

Company Stage

IPO

Headquarters

Town of Greenburgh, New York

Founded

1988

Simplify Jobs

Simplify's Take

What believers are saying

  • Regeneron is expanding its Tarrytown campus, creating 1,000 high-skill jobs.
  • Dupixent approved as first targeted therapy for chronic spontaneous urticaria in a decade.
  • Regeneron invests in AI and machine learning for efficient drug discovery.

What critics are saying

  • Heavy investment in Tarrytown expansion poses financial risk if returns don't materialize.
  • Dependency on Fujifilm partnership may pose operational challenges.
  • FDA rejection of Dupixent for CSU highlights regulatory setback risks.

What makes Regeneron Pharmaceuticals unique

  • Regeneron leverages proprietary VelociSuite technologies for rapid biologic development.
  • The company collaborates with academic institutions to enhance R&D efforts.
  • Regeneron focuses on bispecific antibodies for comprehensive treatment approaches.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours

Company News

Pharma Journalist
Apr 24th, 2025
Regeneron Invests in Expanding Biologic Medicine Manufacturing

Regeneron continues to invest heavily in its New York State operations, where an approximately $3.6 billion expansion of its Tarrytown campus is underway, creating 1,000 full-time, high-skill jobs and expanding research, preclinical manufacturing and support facilities.

PharmiWeb
Apr 24th, 2025
Dupixent Approved In The Us As The First New Targeted Therapy In Over A Decade For Chronic Spontaneous Urticaria

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticariaApproval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placeboIn the US, there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatmentCSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approvedParis and Tarrytown, NY, April 18, 2025. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.Kenneth MendezPresident and Chief Executive Officer at the Asthma and Allergy Foundation of America“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives. The approval of this treatment offers patients more options and the chance to control their disease.”Alyssa Johnsen, M.D., Ph.D.Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi“CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living. This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options.”The US approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Both studies met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks

Texas Border Business
Apr 23rd, 2025
America's Manufacturing Power Surges as Global Giants Invest Billions

Additionally, Regeneron is investing approximately $3.6 billion to expand its Tarrytown, New York facility, aiming to double its manufacturing capabilities nearly.

Pharmaceutical Technology
Apr 22nd, 2025
Regeneron partners with Fujifilm to broaden manufacturing capacity

Regeneron Pharmaceuticals has entered a new manufacturing and supply agreement with Fujifilm Diosynth Biotechnologies to broaden its capacity.

BioSpace
Apr 14th, 2025
Fda Action Alert: Regeneron, Sanofi And Abeona

The FDA has three big decisions slated for the back half of April, two of which are for Regeneron’s blockbuster franchises.Read below for more.Regeneron, Sanofi Eye Another Expansion for DupixentFollowing an initial rejection in October 2023, Regeneron and Sanofi are again trying to expand their anti-inflammatory antibody Dupixent into chronic spontaneous urticaria (CSU). The FDA’s decision is due on April 18.To support their bid for label expansion, the pharma partners submitted data from the Phase III LIBERTY-CUPID clinical program. Data from Study A, released in July 2021, showed that Dupixent could nearly double itch reduction and urticaria activity scores versus antihistamines. Study B, meanwhile, found a numeric improvement in itching and hives versus antihistamines in patients refractory to omalizumab, as per a February 2022 readout, though the study did not reach statistical significance. It was terminated due to futility.These two studies formed the backbone of Dupixent’s initial failed attempt at an approval for CSU, which the FDA rebuffed due to the lack of efficacy data. In their resubmission, Regeneron and Sanofi filed additional data from a third trial, dubbed Study C, which also showed a nearly 50% drop in itch and urticaria activity.If approved, Dupixent would be the first targeted option for CSU in a decade, according to a November 2024 news release.Regeneron Proposes Longer Dosing Interval for Eylea HDIn a bid to maintain the market dominance of its blockbuster biologic Eylea, Regeneron is working to improve the product profile of the high-dose (HD) formulation of the drug