17 jobs found in Conshohocken, PA

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration....

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Job Summary: The Senior Director, Legal – Global Market Access Counsel will serve as a legal advisor for the company’s market access function. This role is responsible for providing strategic counsel and legal oversight on matters relating to distribution, product purchasing agreements, pricing, reimbursement, health technology assessments (HTAs), tendering, and...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Job Summary: Drive the delivery of technology solutions and digital transformation initiatives within R&D and Quality. In this hands-on, execution-focused role, you will work closely with our R&D and Quality business partners to understand existing and emerging processes, gather and refine requirements, and help translate business needs into best-in-class...

As a Senior Specialist, Global Procurement you will support the planning and execution of procurement initiatives using the procure to contract process for Regulatory Affairs & Health Economics and Outcomes Research. This position will conduct data gathering, support spend analytics, assist in delivering measurable cost savings, and monitor savings against contract. You will support evaluations through the development of RFQs, RFIs and RFPs, collectively RFx, and may participate in negotiations. The Senior Specialist will support all vendor sourcing activities which includes but is not limited to preparing QBR data and measuring supplier performance.  A typical day may include the following: Works to support procurement and category management-related initiatives.  Use sourcing system tools and techniques to meet business needs and issues while supporting collaborators and category teams. Provides comparative financial analysis when required for sourcing & procurement...

Job Title: Senior Manager Federal Government Contracts US About the Job The Senior Manager, Government Accounts will report to the Director, Government Accounts and is responsible for recommending and implementing government contracting and pricing strategies for vaccines, managing contract negotiations while executing approved strategies, and all aspects of account management for and in compliance with various government agencies/contracts, including the calculation and remittance of all fees/rebates for government contracts. This role will also support the Director, Government Accounts with various internal/external reporting requirements and ad hoc projects relating to government accounts. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy...

Regeneron Pharmaceuticals Inc. is seeking a Director Patent Attorney to develop global IP strategies around key molecules, platforms and other technologies to ensure Regeneron’s long-term competitive advantage. This unique in-house opportunity will be part of a high-performing team of IP practitioners devoted to protecting Regeneron’s innovations derived from Regeneron’s cutting-edge science and numerous collaborations, including over 75 collaboration agreements executed in the past 5 years. The patent attorney will enable key synergistic collaborations and acquisitions by providing IP transactional and due diligence support in close partnership with colleagues in the R&D, clinical, regulatory, legal, business and alliance management departments at Regeneron. This role will also advise on emerging legal issues, including monitoring and reviewing case law and legislative developments, and is expected to contribute to administrative and legal projects intended to develop an IP...

This Senior Director, Corporate Compliance role is a strategic and dynamic role serving as a Compliance Navigator/Advisor to various areas of the business, with a particular focus on supporting Regeneron’s Global Immunology team. This individual will conduct day-to-day risk assessment and management to help support the vision for Compliance at Regeneron, by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison and primary point of contact for Compliance-related topics to assigned areas of the business, including headquarters and field-based Commercial and Medical Affairs teams. This individual will integrate practical compliance best practices within business processes. In addition, this individual will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify Compliance risks and enhance monitoring opportunities. This individual will be expected to...

Our Regeneron Global Procurement Team is looking for a Manager, Global Procurement supporting the CMO (Contract Manufacturing Organization) space with experience in end-to-end procurement strategies, processes, and global category execution. This Manager will be a part of an amazing team reporting to the Director of Global Procurement - Direct organization. Do you want to be part of something great? Join us! Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron's unique ability to translate science repeatedly and consistently into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron's laboratories. A typical day might include the following: Leading and working with others to solve issues of diverse scope and provide analysis...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron’s Data Governance systems and practices meet the highest standards of regulatory & industry compliance. The post-holder is responsible for providing specialized knowledge and expertise in the design of Data Governance (DG) frameworks, policies & procedures that are aligned with regulatory requirements and industry standards.     In this role, a typical day might include the following:   Assess current and evolving regulatory guidance & industrial intelligence in relation to IOPS business practices.   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices . Technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and that the...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia. In this role, you will be expected to develop and implement strategies to translate CMC intelligence gathering into action and influence policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence , a typical day might include the following Provides oversight on the IOPS CMC intelligence program Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout IOPS Monitors and assesses...

The Manager, Global Procurement – Facilities & Capital Equipment, will report to the Associate Director, Global Procurement – Facilities, Capital & Logistics (FC&L) and is responsible for developing and driving strategy for our responsible categories such as facilities services, capital equipment, and construction. They work collaboratively with teammates as well as cross-functionally with partners across all Regeneron campuses. The Manager owns supplier relationship, actively participates in supplier selection, and manages ongoing performance and service delivery. A Typical Day may include: Leading and collaborating with others to solve issues of diverse scope and provide analysis considering current business trends Continuous Improvement projects to improve efficiency and produce high quality work Negotiating internally and externally to get the best value for Regeneron Drafting and negotiating contracts (regional/global), while working with internal legal...

The Data Governance (DG) ECM champions a culture of data governance within their site by ensuring compliance with DG policies; crafting and delivering relevant training; and monitoring DG practices. The role is pivotal in promoting data stewardship, improving data quality and ensuring DG principles are embedded in the site culture. As a Senior GMP Data Governance & Engagement Specialist, a typical day might include the following: Working in conjunction with the Global DG (Policy & Programs) Team to craft & deliver continuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs. This includes: Crafting, developing & delivery of comprehensive training programs focused on DG, compliance with regulations, and standard methodologies for bio-pharmaceutical manufacturing while using e-learning platforms, simulation tools, and virtual training environments Assess industry trends and regulatory updates on training needs and...

Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab-based position.  This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory departments through the development of strategic plans to support change management activities and documentation related to implementation and maintenance of process control programs for bulk drug substance / formulated drug substance, drug product, combination product, and advanced therapies manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, our Compliance Specialists have an opportunity to work on countless aspects of the process and business. As a Compliance Specialist, a typical day might include the following: Craft business plans to independently advance change control initiatives to implement lifecycle activities of established manufacturing control strategies in support of Global Process...