Regeneron Pharmaceuticals, Inc.

Our Principal Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron’s sophisticated biopharmaceutical manufacturing processes. As a Principal Automation Engineer you will be a site Subject Matter Expert on automated process control and monitoring systems and will be recognized as a technical leader by peers and business partners. As a Principal Automation Engineer, a typical day might include the following: Independently managing or providing leadership to all phases of automation engineering projects and leading all aspects of these projects from conception, design and initial specifications through completion and turnover. Developing detailed and accurate project schedules while collaborating with internal multi-functional teams, end users, and third party contacts to design, develop, document and maintain...

The Regeneron Associate Director QA Auditing-GLP is a key position in the Quality Assurance and Auditing group and will provide professional expertise, guidance, and leadership for the GLP Audit Program. This individual will create strategic partnerships and direct risk-based quality auditing activities across Preclinical Development (GLP). This individual applies expertise in Good Laboratory and international regulations and guidelines to the auditing process to independently address a variety of compliance issues associated with drug development. This individual is responsible for ensuring auditors have the education, experience and/or training necessary to be able to identify compliance issues and negotiate resolution in a highly autonomous manner. The individual should have an expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development including HIPAA Privacy Rule, and other international and...

As a Senior Manager, you will work closely with the HEOR therapeutic leads to support the execution of our strategies. The Senior manager will support the formulation of our plans and studies to ensure implementation.A typical day may include: Execution of global and regional HEOR strategies and programs for our products to advise, support and strengthen commercialization activities, including clinical development, marketing, and market access.Work directly with cross functional and business partners to develop and support compelling product value propositions with aim to optimize access, reimbursement and uptake.Identifying HEOR evidence requirements and gaps, and design, conduct, and deliver studies and tools to support relative value demonstration and product differentiation (e.g. prospective and retrospective observational studies, real world data analyses, registry studies, PRO studies, cost effectiveness and budget impact analyses, modeling studies).Conducting population and...

The ED, Medical Affairs (General Medicine; GM, including Infectious Diseases - ID) will report to the Head of Medical Affairs with primary responsibility to lead and ensure execution of all programs and functions associated with the late stage development and medical aspects of commercialization of GM/ID assets at Regeneron. In addition to leading the strategy and executional elements of phase IV (post-marketing) and investigator initiated studies program, the role includes being a thought partner with our clinical development colleagues for the purpose of driving innovative GM/ID development strategies, as well as being a collaborator with commercial colleagues helping to ensure strategies benefit from the insight of an experienced clinician. As the ED, Medical Affairs, a typical day might include the following:Providing deep GM/ID expertise to a rapidly expanding and advancing GM/ID portfolio that will cover many molecules and a multiplicity of Ab platforms, all developed and...

We are looking for a Sr Principal Bioinformatics IT Engineer to work on scientific systems supporting research scientist. You will be responsible for existing applications in genomics, proteomics and image analysis. You should be adept at working with large datasets to find opportunities for data utilization, harmonization and process improvements. You will be passionate about finding solutions in novel ways by uncovering new methods and patterns in our existing data ecosystem.In this role, a typical day might include performing the following:Work with the partners throughout the research and preclinical development group to use existing scientific data to drive innovation and business solutions.Use data mining and analysis in partnership with research partners.Responsible for algorithm development focused on life sciences datasets.Build predictive models to increase and optimize discovery opportunities.Integrate existing systems into a broader data model and data lake.This job...

The QC Data Analyst (Assoc-Sr III) performs and executes a variety of activities to support release and stability programs. We are looking for someone who can optimally collaborate with members of manufacturing, QA, RA, and R/D to provide updates and statuses of CofAs, SofAs, testing issues, and more. This role continuously ensures compliance with applicable cGMP regulations and SOPs while driving performance and success throughout the team. As the QC Data Analyst (Assoc- Sr III), a typical day might include the following:• Gathering internally and externally generated data in support of CofAs and SofAs• Preparing and providing all lot release materials and trending QC release data to support lot release and regulatory fillings• Acting as a liaison between QC, Process Analytical Sciences, and Manufacturing groups to provide analyses• Assisting in the implementation and maintenance of product release data trending program for each product candidate• Actively presenting valuable data...

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 architecture, design and implementation of reliable infrastructure services on AWS, from the ground up, to deliver highly scalable services. You will work with stakeholders, technology team leadership, and subject matter experts to analyze, design, build, and implement cloud platform solutions and DevOps processes needed within RGC. You will also be responsible for management of operational support and coordination with internal IT teams to ensure security, scalability and reliability of the RGC cloud platform.Key focus areas includeDevelop and own best practices/methodologies for provisioning, application scaling, configuration management, capacity planning, monitoring, etc.Drive automation, DevOps and Infrastructure as code (IaC) best practices...

We are currently looking to fill a Process Technician with a Wednesday - Saturday 2:00PM - 12:30AM schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance and troubleshooting support for manufacturing process area maintenance through strict adherence to Standard Operating Procedures (SOPs) and cGMP's.As a Process Technician, a typical day might include the following:• Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment with minimal direction• Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment with strict adherence to SOP's, cGMP's, and quality standards• Identifying any off-nominal...