22 science jobs found

Within this role you will support the Process Sciences laboratory operations by supporting adherence to site policies and procedures associated with but not limited to good documentation practices, data integrity considerations, equipment and vendor maintenance and PS study execution, recording and reporting. As a Compliance Specialist within Process Sciences, a typical day might include, but is not limited to, the following:   Ensuring oversight and support for PS laboratory operations comply with site data integrity policies and procedures. participating in ATRAs, audit trails reviews, data recording, storage, and verification Maintaining laboratory records in accordance with site procedures is essential. Types of records include paper and electronic lab notebooks, laboratory logbooks, equipment maintenance records, and laboratory study protocols and reports Completing quality records such as deviations, CAPAs, and change controls with support and oversight...

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...

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...

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.  Your Role: You’ll be joining a highly collaborative Analytics & Insights team that sits at the center of Baxter’s commercial data ecosystem. This group partners closely with Government Contracts,...

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 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...

Career Category Information Systems Job Description Role Overview: We are seeking a highly motivated and detail-oriented Data Governance Specialist to join our Data Strategy & Governance team. This role will be pivotal in ensuring that data privacy policies and controls defined by the Central Data Team (CDT) and Data Privacy Office are effectively implemented and enforced across our data hubs and platforms. The ideal candidate will have a strong understanding of data governance frameworks, privacy regulations, and enterprise data management practices. Key Responsibilities: Policy Enforcement: Ensure that privacy policies, data handling standards, and control mechanisms published by CDT and Data Privacy teams are consistently applied across all data platforms and hubs. Governance Frameworks: Support the development, implementation, and maintenance of data governance frameworks, including data ownership, stewardship, and classification models....

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 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...

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...

Within this role you will be responsible for initiating, leading and executing compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management. As a Supply Compliance Senior / Analyst, a typical day might include, but is not limited to, the following: Developing an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance related policies and procedures Acting as a liaison between the Supply Chain departments and onsite quality and regulatory groups to define and address all issues of non-compliance Facilitating all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department Providing support, information and assistance to individual groups and supervisors with the initiation, review, submission and follow-up of documents such as CCs, NOEs, DNFs, impact statements...

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...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering new approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. In this role typical day might include performing the following: The Senior Manager of Contracting at the Global Procurement Capability Centre in Bengaluru will supervise the establishment and leadership of a new team. This team will be integral to the Capability Centre's mission to fulfill Global Procurement duties at Regeneron. The incumbent will lead a group of dedicated professionals focused on providing contracting expertise to support global procurement initiatives. The role will enable consistency, scalability and efficiency for repeatable, location...

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...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative ways to science, manufacturing, and commercialization, as well as redefining our understanding of health. Senior Specialist – Contracting Global Procurement Capability Centre in Bengaluru will be an individual contributor and supporting the contracting capabilities within a newly formed Capability center to enable delivery of Global Procurement responsibilities at Regeneron. The role will be demonstrating a systemic approach for buying goods and services while applying procurement applications to provide efficient and effective contract execution. The role will maintain consistency, scalability and efficiency for repeatable, location agnostic contracting across...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative ways to science, manufacturing, and commercialization, as well as redefining our understanding of health. Senior Specialist – Contracting Global Procurement Capability Centre in Bengaluru will be an individual contributor and supporting the contracting capabilities within a newly formed Capability center to enable delivery of Global Procurement responsibilities at Regeneron. The role will be demonstrating a systemic approach for buying goods and services while applying procurement applications to provide efficient and effective contract execution. The role will maintain consistency, scalability and efficiency for repeatable, location agnostic contracting across...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Sr. Learning Technology & Governance Specialist is responsible for bridging learning experience design, commercial enablement, and technology. This role supports the commercial organization in adopting and effectively using learning technologies while establishing a scalable content governance framework across the learning ecosystem. The responsibilities of the Sr. Learning Technology & Content Governance Specialist include managing and optimizing learning technologies; supporting vendor relationship management; and designing, implementing, and operationalizing content...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Sr. Logistics Compliance Specialist, International will support efforts as it relates to international product movements, dangerous goods / hazmat regulatory adherence, and audit-ready process management. The incumbent will be the SME and primary point of contact for International Trade regulations supporting our product movements into/out of all countries we operate in, and supporting International Product Rollouts in all global regions. This role will be responsible for identifying import and export requirements in various countries, summarizing and managing regulatory...

Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in a compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. As Director of GMP Compliance & Inspections a typical day may include, but is not limited to, the following:   Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems Leading proactive evaluation and education of site GMP compliance against current and emerging...