Full-Time

IT Lead – Manufacturing Gxp

Posted on 6/13/2026

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops biopharmaceutical therapies for serious diseases

Compensation Overview

$80.3k - $131.1k/yr

Cambridge, MA, USA

In Person

On-site role based in Cambridge, MA; confirm on-site requirements with recruiter.

Category
IT & Security
Required Skills
Quality Assurance (QA)
Requirements
  • Bachelor’s degree in information technology, Computer Science, or a related field.
  • 5 – 10 years' demonstrated ability in an IT role, preferably within a GMP-regulated environment.
  • Proficiency in troubleshooting all IT aspects of manufacturing/QC equipment and other data collection/monitoring systems (e.g. EMS).
  • Familiarity with GMP requirements and IT compliance standards.
Responsibilities
  • Serve as the primary point of contact between RCM and Corporate IT, coordinating support across internal groups and external vendors.
  • Align IT services with RCM’s needs by facilitating clear stakeholder communication on requirements, timelines, and deliverables.
  • Lead planning and execution of IT projects and initiatives within a GMP environment, ensuring effective cross-team coordination.
  • Provide regular operational and project status updates, metrics, and risk/issue reports to leadership.
  • Manage and direct contracted IT personnel and oversee vendor performance for service delivery.
  • Troubleshoot and resolve on-site IT issues for manufacturing, QC equipment, and facilities systems (hardware/software), ensuring rapid restoration.
  • Ensure high availability and resilience of critical systems through monitoring, preventive maintenance, backups/archiving, and recovery readiness.
  • Develop and maintain GxP documentation, including specifications, test protocols, validation/CSV records, and system administration SOPs.
  • Support integration of equipment and systems with LIMS and other enterprise platforms in coordination with Corporate IT; supervise EMS for compliance and reliability.
  • Ensure GMP/regulatory compliance by partnering with QA, managing IT tasks in CMMS, maintaining audit readiness, and driving continuous improvement of workflows and support processes.
Desired Qualifications
  • None
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company Size

10,001+

Company Stage

IPO

Headquarters

Town of Mount Pleasant, New York

Founded

1988

Your Connections

People at Regeneron Pharmaceuticals who can refer or advise you

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Simplify's Take

What believers are saying

  • Sanofi collaboration profits accelerate after mid-year repayment ends, boosting high-margin cash flow.
  • DUPIXENT and EYLEA remain large commercial anchors supporting R&D investment.
  • New platforms in metabolic disease, oncology, and Helicon conjugates broaden future growth options.

What critics are saying

  • DUPIXENT concentration makes growth vulnerable if competitive pressure or demand slows.
  • Fianlimab's Phase III melanoma failure weakens oncology credibility against entrenched rivals like Keytruda.
  • Parabilis and other platform bets can consume capital without producing approved medicines.

What makes Regeneron Pharmaceuticals unique

  • Regeneron has 14 internally discovered medicines and 40 candidates across many therapeutic areas.
  • Its proprietary VelocImmune, VelociSuite, and Genetics Center support repeated drug discovery.
  • The company pairs core franchises with collaborations, including Sanofi, Parabilis, and Telix.

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Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

11%

1 year growth

11%

2 year growth

11%
Regeneron Pharmaceuticals
May 19th, 2026
Regeneron Announces Strategic Collaboration with Parabilis Medicines to Advance Novel Antibody-Helicon™ Conjugates Across Multiple Therapeutic Areas | Regeneron Pharmaceuticals Inc.

The multi-target collaboration combines Regeneron’s industry-leading antibody capabilities with Parabilis’ novel Helicon™ peptide platform  Agreement provides for Parabilis to receive $125M from Regeneron, consisting of a $50M upfront payment and $75M equity commitment, with up to approximately

Endpoints News
Apr 13th, 2026
Regeneron wades into radiopharma through $40M upfront deal with telix.

Regeneron wades into radiopharma through $40M upfront deal with telix. News reporter. Regeneron is set to work on radiopharmaceuticals for the first time in a new partnership to develop solid tumor therapies as... Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox. Think Endpoints Company is worth reading - tell google. Confirm Endpoints as a trusted biopharma news source ENDPOINTS CAREERS TCG stealth clinic-ready newco.

AllSci
Apr 13th, 2026
Telix partners with Regeneron on radiopharmaceutical therapies in USD 2.1b potential deal.

Telix partners with Regeneron on radiopharmaceutical therapies in USD 2.1b potential deal. April 13, 2026 Australia-based Telix Pharmaceuticals Ltd (ASX: TLX, Nasdaq: TLX) and US firm Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced a strategic collaboration to jointly develop and commercialize next-generation antibody-based radiopharmaceutical therapies across multiple solid tumor indications. The agreement pairs Telix's radiopharmaceutical development platform and global manufacturing infrastructure with Regeneron's antibody discovery technologies, including its VelocImmune and VelociSuite platforms, to generate a pipeline of radiolabeled biologics. Specific tumor targets have not been disclosed. Deal specifics. Under the deal terms, Telix will receive an upfront payment of USD 40 million from Regeneron for access to its radiopharmaceutical manufacturing platform across four initial therapeutic programs. Should Telix elect to opt out of co-funding on any individual program, it becomes eligible to receive up to USD 535 million in development and commercial milestone payments per program, plus low double-digit royalties on net sales, with an aggregate milestone ceiling of USD 2.1 billion across all programs. Where Telix remains in the co-funding model, the two companies will share equally in global development costs and commercialization profits on a 50/50 basis, with Telix retaining the option to co-promote certain products. The collaboration covers four initial therapeutic programs, with Regeneron holding the option to expand to four additional programs subject to further upfront payments. The parties will also jointly develop radio-diagnostic assets to support patient selection and treatment response monitoring, with Telix leading commercialization of those diagnostics and Regeneron receiving a defined percentage of profits. The exact percentage was not disclosed. The structure gives Telix a per-program election right at a defined decision point: co-fund and share in global profits equally, or opt out and revert to a milestone-plus-royalty economics model. This optionality allows Telix to allocate capital selectively depending on program progression and resource constraints, while preserving upside participation across the portfolio. The agreement is global in scope, with no geographic carve-outs or territorial allocations disclosed. No equity investment by either party in the other was announced in connection with the transaction. The drug programs will combine Regeneron's antibody targeting components, drawn from its portfolio of antibodies generated through VelocImmune mice, with Telix's radiolabeling and manufacturing capabilities. The modality class is antibody-based radiopharmaceutical therapy, in which a tumor-antigen-binding antibody serves as the targeting vehicle for a therapeutic radionuclide payload. The collaboration also encompasses potential bispecific antibody formats, given Regeneron's established expertise in that area. Regeneron noted in its public commentary that it intends to explore these agents as monotherapy and in rational combination with its immunotherapy platform, citing lung cancer as one area of interest where its PD-1 inhibitor is already in use. The specific antigens, antibody names, and radionuclide payloads for the collaboration programs have not been publicly identified. The theranostic component of the agreement, pairing matched diagnostic and therapeutic agents using the same antibody targeting vector, supports patient stratification and dosimetry assessment ahead of and during treatment. Telix will lead commercialization of the diagnostic assets developed under the collaboration. Strategic implications. Regeneron's entry into radiopharmaceutical oncology drug development marks a modality expansion for a company whose oncology portfolio has been anchored in antibody-based immunotherapy. The company indicated it views targeted radiopharmaceuticals as a frontier in oncology and has framed the collaboration as an opportunity to apply its antibody discovery engine to a delivery modality it has not previously pursued commercially. For Telix, the arrangement provides validation of its radiopharmaceutical manufacturing infrastructure as a platform asset capable of attracting large-scale co-development partnerships. Telix's existing commercial radiopharmaceutical portfolio includes Illuccix kit for the preparation of Ga-68 Glu-urea-Lys(ahx)-hbed-CC injection (also known as 68Ga-PSMA-11 injection), approved by the US FDA as a prostate cancer imaging agent. In addition, the firm announced on April 9, 2026, that the US FDA has accepted an NDA filing for TLX101-Px (Pixclara, Floretyrosine F 18 or 18F-FET), an investigational PET agent for the imaging of glioma (brain cancer). Your email address will not be published. Required fields are marked *

GlobalData
Apr 13th, 2026
Telix and Regeneron to co-develop radiopharmaceutical therapies.

Telix and Regeneron to co-develop radiopharmaceutical therapies. The partnership reflects a focus on precision oncology, seeking to enhance patient selection and assess treatment responses. Telix and Regeneron Pharmaceuticals have entered a partnership for the development and commercialisation of new radiopharmaceutical therapies. This collaboration aims to integrate Telix's expertise in radiopharmaceutical platforms, global manufacturing and supply chain infrastructure with Regeneron's biologics knowledge, particularly in bispecific antibody discovery. Regeneron will initially provide Telix with an upfront cash payment of $40m for access to the latter's radiopharmaceutical manufacturing platform for four therapeutic initiatives. There is an option for Regeneron to expand to another four programmes, which would involve further upfront payments. Both companies will equally share the costs and potential profits worldwide, with Telix optionally co-promoting certain products. If Telix chooses to step back from funding a specific programme, it could gain up to $535m in developmental and commercial milestones, in addition to low double-digit royalties on subsequent net sales. Regeneron oncology and antibody technology research senior vice-president John Lin said: "At Regeneron, Pharmaceutical Technology follow the science to determine the best therapeutic approach for each disease, continuously expanding its toolbox of treatment modalities - from monoclonal and bispecific antibodies to cell therapies and beyond. "Targeted radiopharmaceuticals represent a rapidly emerging frontier in oncology and an exciting opportunity to bring new treatment options to patients in need." The collaboration will include several solid tumour targets from Regeneron's antibody portfolio, benefiting from its VelocImmune mice technology. It reflects a joint focus on precision oncology, seeking to enhance patient selection and assess treatment responses through new radio-diagnostics. The companies also plan to develop diagnostic assets, where Telix will spearhead the commercialisation efforts, and Regeneron will receive a predetermined share of the profits. In December 2025, Regeneron teamed up with Tessera Therapeutics to develop and commercialise Tessera's rare disease in vivo gene writing programme, TSRA-196. Give your business an edge with its leading industry insights.

Yahoo Finance
Apr 13th, 2026
Dupixent approved in EU as first targeted medicine for chronic spontaneous urticaria in children aged 2-11

Regeneron Pharmaceuticals and Sanofi announced that the European Commission has approved Dupixent (dupilumab) for treating moderate-to-severe chronic spontaneous urticaria in children aged 2 to 11 years. The approval applies to patients with inadequate response to histamine-1 antihistamines who are naïve to anti-immunoglobulin E therapy. This expands Dupixent's existing EU approval for CSU, which previously covered adults and adolescents aged 12 and older. The drug is now approved for children under 12 across four chronic diseases driven partly by type 2 inflammation. The approval is based on data from the LIBERTY-CUPID clinical trial programme, including efficacy data extrapolated from two Phase 3 adult trials and pharmacokinetic, safety and efficacy data from the CUPIDKids Phase 3 trial in children aged 2 to 11.