procedures.
In this role, a typical day may include:
Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices.
Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, 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 against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports.
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, including those listed above.
Provide direction and assign 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.
This role might be a fit for you if you:
Have strong leadership and project management skills.
Thrive in a quality focused environment.
Possess a positive, proactive approach to drive projects/tasks to completion.
Are able to mentor and encourage others.
Gowning and Environment
Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for this role you must hold a Bachelor’s degree in Chemistry, Engineering, or Life Sciences and the following years of experience for each level:
Manager: 7 + years
Sr. Manager: 8+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
Full-Time
Confirmed live in the last 24 hours
Develops biopharmaceuticals for serious diseases
$104.3k - $199k/yr
Senior, Expert
Albany, NY, USA
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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
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Health Insurance
Wellness Program
Paid Vacation
Equity Awards
Annual Bonuses
Flexible Work Hours
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.
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
Additionally, Regeneron is investing approximately $3.6 billion to expand its Tarrytown, New York facility, aiming to double its manufacturing capabilities nearly.
Regeneron Pharmaceuticals has entered a new manufacturing and supply agreement with Fujifilm Diosynth Biotechnologies to broaden its capacity.
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