regeneron

Nov 09, 2024
regeneron Tarrytown, NY, USA
The Regeneron Genetics Center IT group seeks a Technical Lead for their Application Development team.  You will be responsible for providing technical leadership and oversight of a growing portfolio of solutions that empower our scientists’ research and discovery. This is a hands-on technical position with opportunities to speak to internal clients and manage work end to end. As a Technical Lead, a typical day might include: Developing solutions across the entire stack from web applications to cloud based APIs and services using JavaScript and AWS services. Engaging with internal clients to understand use cases and gather feedback. Managing technical work and timelines. Prioritizing and completing multiple initiatives in an agile environment. Coordinating cloud based (AWS) infrastructure with DevOps team. Keeping informed of new and emerging technologies to incorporate into our technical stack. Ensuring alignment to architecture guidelines and...
Nov 09, 2024
regeneron Tarrytown, NY, USA
The Medical Director, Clinical Sciences should be a qualified physician with pharmaceutical industry experience, preferably in Ophthalmology Therapeutics Development. The Director will serve as Medical Lead for clinical trials in the CDP and is responsible for the design of clinical study concepts leading to clinical trial protocols. This role requires a high-performing and highly passionate physician scientist who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. As a Medical Director, a typical day may include the following responsibilities: Acts as medical expert and leader in interactions with external stakeholders Defines clinical trial-related Clinical Development Program (CDP) goals and objectives  Works closely with discovery teams to provide input on the next generation of targets in the field Responsible for the relevance and accuracy of medical science underpinning...
Nov 09, 2024
regeneron Tarrytown, NY, USA
We are seeking a qualified physician scientist with significant pharmaceutical/biotechnology sector and/or exceptional academic clinical trials' experience. With oversight from supervisor, works with other members of the cross-functional team to interface with research functions and evaluate emerging targets, conceptualize and document clinical development program strategies, author clinical development protocols and facilitate/lead execution of study activities and data summarization. As appropriate will also participate in business development activities and in collaborations with key partners outside of Regeneron. The Neuroscience Therapeutic Area encompasses programs for Central Nervous System, Peripheral Nervous System, Neuromuscular and Muscular Diseases. As a Senior Medical Director, a typical day may include the following: Leads the clinical science function at the Strategic Program Team, represents clinical and experimental science functions at that Team, including...
Nov 09, 2024
regeneron Rensselaer, NY, USA
We are currently looking to add a Cleanroom & HEPA Certification Specialist to our growing team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Cleanroom & HEPA Certification Specialist will support our manufacturing by coordinating the performance of preventive maintenance and on-demand work of certification activities. As a Cleanroom & HEPA Certification Specialist, a typical day might include the following: Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled PM or general work Working with Certification Vendor(s) and Regeneron Facilities, Manufacturing and Lab Management Scheduling Groups to ensure timely certifications of HEPA filtered areas and equipment Recording certification activities in electronic records Ensuring safe and efficient maintenance of all Cleanroom and HEPA supplied...
Nov 09, 2024
regeneron Tarrytown, NY, USA
As a Senior Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio. In this capacity the Senior Director is accountable for the successful and timely completion of all assignments encompassing a broad array of deliverables in support of the corporate strategic goals. The Senior Director is expected to apply both logistical and strategic initiatives as well as to incorporate novel and creative scientific approaches. A typical day in this role might look like: Utilizing a mastery level of PK/PD knowledge and strategic leadership skills, effectively develop and implement strategic analyses in support of research and development projects. • Adapts plans and priorities that addresses resource and operational challenges. Accountable for the appropriate application of PMx and corporate policies and procedure. • May...
Nov 09, 2024
regeneron Chicago, IL, USA
As an Associate Director, Field Medical Affairs you be a field facing representative engaging in the exchange of scientific data, medical or information with KOLs, HCPs, researchers, pharmacists and population-based decision makers. We are to demonstrate a thorough understanding of B-Cell Malignancies including NHL and Multiple Myeloma aligned with our strategic plans. Territory: Chicago/northern IL, WI, MI (upper pennisula A typical day may include the following: Identifying and maintaining a list of relevant medical/therapeutic area experts, investigator targets and associated plans of action. Establishing, fostering, cultivating and maintaining peer relationships with KOLs in Hematological Malignancies Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Regeneron’s product ensuring awareness and understanding. Participates in the development and management of company sponsored clinical trials...
Nov 09, 2024
regeneron Rensselaer, NY, USA
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...
Nov 09, 2024
regeneron Tarrytown, NY, USA
The Senior Lab Coordinator position is part of the Workplace Strategy & Planning team and partners with internal resources, consultants, contractors, and the Regeneron Community to support the coordination of Workplace Strategy & Planning projects and day-to-day activities related to labs. The Senior Lab Coordinator will assist in the project scheduling and resource planning, procurement, and installation of lab furniture, fixtures, equipment, and all MAC activities. Provides excellent customer service for furniture, fixtures & equipment, and Moves, Adds & Changes (MAC) activities to end-users. A typical day might include: Build relationships and partner with lab planners and lab champions or requestors to gather requirements and plan/coordinate laboratory activities. Acting as the primary liaison to lab planners and end users to ensure requests are efficiently allocated and installation schedules are communicated and aligned with critical needs. Report and...
Nov 09, 2024
regeneron Tarrytown, NY, USA
The Genome Informatics and Data Engineering team is looking for a passionate Lead Cloud DevOps Engineer with strong technical ability, communication, and collaboration skills. As the Lead Cloud DevOps Engineer, you will be responsible for managing AWS platform, implementation & management of solutions on AWS, from the ground up, to deliver highly scalable services. You will work with stakeholders, rest of the DevOps team, and subject matter experts to build and implement cloud platform solutions. Key focus areas include: Creating & managing containerized applications Building & optimizing CI/CD pipelines and enabling automated deployment of solutions on AWS Cloud with code quality and security testing Support core AWS services – S3, EC2, ECS, EFS, IAM, Lambda, RDS, Redshift, Cloud Formation and develop python & bash scripts for automating routine operations Good to have: Understanding of Data & Analytics. Knowledge on Slurm. Knowledge on WDL....
Nov 09, 2024
regeneron USA
The Manager Regulatory Publishing will be accountable for formatting and publishing electronic documents and building regulatory submission results such as INDs, CTAs, BLAs, MAAs & JNDAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA, ICH, etc) As a Manager Regulatory Publishing, a typical day might include the following: Leads staff and/or vendors who electronically format, publish electronic documents and builds Regulatory submission results. Ensures quality, accuracy, and submission-readiness per Regulatory agency mentorship and specifications, and internal procedures. Provides mentorship to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA ICH, etc) Provides mentorship on good documentation and submission practices....
Nov 09, 2024
regeneron Tarrytown, NY, USA
The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Sr. Manager reports to Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the following: Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam Develops/maintains...
Nov 09, 2024
regeneron USA
As an Associate Director, Field Medical Affairs you be a field facing representative engaging in the exchange of scientific data, medical or information with KOLs, HCPs, researchers, pharmacists and population-based decision makers. We are to demonstrate a thorough understanding of B-Cell Malignancies including NHL and Multiple Myeloma aligned with our strategic plans.  Territory: North Carolina, South Caroline, Virginia, Georgia A typical day may include the following:  Identifying and maintaining a list of relevant medical/therapeutic area experts, investigator targets and associated plans of action. Establishing, fostering, cultivating and maintaining peer relationships with KOLs in Hematological Malignancies Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Regeneron’s product ensuring awareness and understanding. Participates in the development and management of company sponsored clinical trials...
Nov 09, 2024
regeneron Bernards, NJ, USA
As a Senior Manager, Global Procurement you will be accountable for supporting the definition and implementation of the global Clinical Core (IRT, eCOA) and Digital Health Technology Category strategy. We work closely with team members managing discussions and aligning category priorities with Procurement management and collaborators. A typical day may include:   Managing negotiations, supplier management activities, and collaborator engagement activities.  Collaborating driving value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Representing Global Procurement by participating in organizational decisions in the Clinical Core (IRT, eCOA) and Digital Health Technology categories with critical short and long-term impact on the success, efficiency, growth, and results. Demonstrates knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and...
Nov 09, 2024
regeneron Sleepy Hollow, NY, USA
As a Director, HEOR you will formulate strategies of our Health Technology Assessment (HTA) submission packages ensuring implementation. The primary responsibilities are to evaluate relevant HTA decisions, apply key findings to pipeline and marketed products. Additionally, you will develop submissions to HTA agencies securing reimbursement. Location: This position will require you to be on-site a minimum of 3 days/week at our Sleepy Hollow, NY location. We are not able to accommodate a fully remote option. If eligible, we can offer relocation benefits. A typical day may include the following: Partner with cross functional and business partners developing and supporting a compelling product value propositions optimizing access, reimbursement and uptake. Provide strategic input and HEOR evidence to support commercial and Government relations lobbying efforts and legislative initiatives. Work alongside regional partners with key payers, industry associations and medical...
Nov 09, 2024
regeneron USA
Within this role you will be responsible for providing technical support on the manufacturing process. You will be a key member in the implementation of large scale commercial manufacturing production program and heavily involved in the technical transfer of processes. This is a shift position, including day and night shift.  As a Process Specialist Downstream, a typical day might include, but is not limited to, the following: Liaising with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process Being the key person for technical input into manufacturing records, batch sheets and procedures Writing and reviewing, Standard Operating Procedures or other controlled documents as needed Providing technical input to resolve process problems both on and off the production suites Working closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve...
Nov 09, 2024
regeneron USA
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...
Nov 09, 2024
regeneron USA
Within this role you will be responsible for the configuration, implementation, maintenance, and ongoing support of various IT applications and systems.   As an IT Applications Analyst , a typical day might include, but is not limited to, the following: Coordinating across business departments and stakeholders, gathering, and implementing requirements and enhancement requests for various applications Providing SME support and working closely with cross-functional departments on projects to enhance system functionality and solving emergent issues Coordinating with other IT Application team members to administer and support production systems in an efficient and compliant manner Handling IT Application documentation tasks, including converting user requirement specifications to a detail design specification, creating configuration test plans, and compiling summary reports Configuring reports (tabular, trend, and labels) Processing IT Applications change control...
Nov 09, 2024
regeneron USA
Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Sciences support Upstream Sciences, Downstream Sciences, Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, Process Validation and Process Solutions. As a Supervisor within Process Sciences a typical day might include, but is not limited to, the following: Coordinating, organizing and assigning the daily/short term activities of operations and supporting employees executing against established guidelines and common procedures & policies Coordinating the provision of technical support to the manufacturing process Coaching, mentoring and developing staff, including overseeing new employee onboarding and providing career development planning and opportunities to direct reports Communicating business and organizational information/priorities and...
Nov 09, 2024
regeneron USA
Within this role you will be responsible for the implementation and day to day operation of the Regeneron Manufacturing Execution System, the integrity of the data within the system and those provided by the associated data exchanges. You will be responsible for ensuring that MES operations fully meets the needs of the business by aligning with Commercial Manufacturing requirements.   As an Associate Manager in MES Operations a typical day might include, but is not limited to, the following: Ensuring that MES system installation aligns with site policies and processes Coordinating the needs of functional groups across the site and establishing the priorities for MES operations Striving for the optimum installation of the system and its continuous process improvement thereafter Reviewing company documentation including SOPs, requirements and Manufacturing Batch Records to assess MES impact Developing strong business relationships with Commercial...
Nov 09, 2024
regeneron USA
Within this role you will be a vital part of a team focused primarily on the implementation and support of Waters Empower Chromatography (CDS) software in a highly regulated cGMP laboratory environment. The systems we support are crucial in the production of Regeneron’s life-saving products. This is a 12-month temporary contract. As a Temp Applications Analyst a typical day might include, but is not limited to, the following: Providing & supporting Empower CDS users; solving problems at the application level as well as hardware troubleshooting Administering user access to software systems; adding, modifying and removing users; defining user types, user groups and security settings Ensuring the application remains in a compliant state by executing change control requests Collaborating closely with laboratory personnel Participating in investigations and root cause analysis Adhering to relevant system software SOPs and policies Supporting system validation and...