Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc. New York, NY, USA
Jul 28, 2021
Full time
The Director, Advanced Analytics - Oncology role is a part of the Insights & Analytics team under Commercial Operations. This role will collaborate with sales and marketing business partners, customer insights and data management teams to develop data driven insights to support brand strategic and tactic decision making. This individual will take the lead on collection, interpretation and integration of all aspects of data sources. This is a hands-on role that owns the translation of a variety of data into meaningful opportunities, provides insights based on a deep knowledge of brands, sales, market environment and evolving health care systems, customers for skin cancer and emerging launches. Identifying business needs proactively and handle the day-to-day relationship and projects with sales leadership and brand teams. Conducting objective secondary data analysis and communicate insight story of synthesizing different sources and types of data. Building out comprehensive...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 27, 2021
Full time
We are looking for a Senior IT Business Analyst to join our expanding IT team. We drive the business forward by delivering new digital capabilities and scaling our systems. Our Business Analysts support the organization by eliciting and documenting requirements, understanding complex business processes, and coordinating communication among the various groups. In this dynamic environment, IT Business Analysts have an opportunity to work on numerous aspects of the process and business. As a Senior IT Business Analyst, a typical day might include the following: • Working closely with IT management and business partners to elicit requirements and document processes in support of delivering new business capabilities • Partnering with a diverse business community to document as-is and to-be business processes • Documenting clear and testable requirements which describe a system to be implemented • Collaborating in the creation, review and approval of validation documents • Utilizing your...
Regeneron Pharmaceuticals, Inc. New York, NY, USA
Jul 27, 2021
Full time
We seek a Senior Accountant that will report to Manager, Accounting. This position will perform accounting duties primarily within the Product Revenue and SG&A expense areas. Responsibilities will include the timely completion of activities within the monthly/quarterly close process timeline; e.g., recording journal entries and preparing revenue, expense and balance sheet account analyses. This position will work with other accounting groups, Finance, Commercial Trade, and other departments to gather the information necessary to prepare schedules and accurately account for the areas for which they are responsible.A typical day might include the following: • Responsible for knowledge of and compliance with the relevant Company Accounting policies. • Assist in performing the Company's Product Revenue Gross-to-Net Accounting, including the related reconciliations, detailed trend analysis of product sales related deductions, and returns reserve analysis. • Assist with the...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 26, 2021
Full time
The Executive Director of Supply Planning & Reporting at IOPS (Industrial Operations Product Supply) drives the development and execution of the Global Supply Chain Planning & Reporting strategy. We are looking for someone to optimally improve supply chain efficiency in meeting demands of a rapidly growing business. This role provides leadership and guidance for all aspects of Sales & Operations Planning while building and owning processes to increase transparency and decision making. As the Executive Director of Supply Planning & Reporting, a typical day might include the following: • Leading Supply Chain Planning & Reporting teams, including sub-functions of Supply Products, Supply Integration and Supply Networks • Collaborating with cross-functional teams on planning product to ensure effective planning of WIP and finished product to meet standards defined by the program development • Designing and implementing collaborative planning and engagement...
Regeneron Pharmaceuticals, Inc. New York, NY, USA
Jul 26, 2021
Full time
The Senior Manager, Commercial Data Science, is an individual contributor role that serves as an advisor to internal customers within the commercial organization. As part of the Advanced Analytics team, the role will collaborate with Sales & Marketing business partners, Customer Insights and Data Management teams to develop predictive and prescriptive models and insights. This is a hands-on role to innovate and deliver analytics that support strategic and tactical decision making for both in-line and pre-launch products. Develop data science, machine learning, and artificial intelligence capabilities across therapeutic areas. Build predictive analytics and data mining by using longitudinal patient data. Build statistical models for marketing mix, program measurement, market event impact analysis, segmentation, early adopter analysis, etc. Provide resource allocation and optimization recommendations to advise business planning. Build high-performance algorithms, prototypes,...
Regeneron Pharmaceuticals, Inc. New York, NY, USA
Jul 26, 2021
Full time
The Associate Manager, Accounting will lead a team of two accountants and be responsible for the Company's accounting related to fixed assets, leases, certain operating expenses and other tasks. In this role you will work with Finance, IT, Facilities, Financial Reporting and other stakeholders to ensure adherence to the Company's accounting policies, provide accounting guidance, and assist with capital expenditure reporting and forecasting. This role will also be responsible for identifying, designing and implementing process improvements.A typical day might include the following: • Ensure capital expenditures are accounted for accurately and in compliance with the Company's accounting policy • Manage the timely and accurate completion of the monthly accounting cycle for areas of responsibility • Preparation and review of journal entries, supporting schedules, account analyses, reconciliations and variance explanations • Responsible for ensuring that (i) effective internal controls...
Regeneron Pharmaceuticals, Inc. New York, NY, USA
Jul 25, 2021
Full time
The Senior Contingent Workforce Coordinator is responsible for handling the flow of contingent workers into and out of company in accordance with predefined pre-clearance, on-boarding, and off-boarding activities and SLAs. Core work streams include supervising the successful completion of background and medical check clearances, start date management, coordination of handoff for building and system access, proactive end date management, off-boarding and the timely removal of site/systems access and asset retrieval at the end of each assignment. As a Sr. Contingent Workforce Coordinator, a typical day might include the following: Providing superior and consultative client service support to all REGN internal users and external suppliers Responding to requests to the NEMO hotline & internal mailbox, working expeditiously to process all inquiries and requests Training Suppliers and REGN users on the use of Beeline, on/off-boarding practices, and documentation requirements...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 25, 2021
Full time
We are looking for an IT Business Analyst to join our expanding IT team. We drive the business forward by delivering new digital capabilities and scaling our systems. Our IT Business Analysts support the organization by eliciting and documenting requirements, understanding complex business processes, and coordinating communication among the various groups. In this dynamic environment, IT Business Analysts have an opportunity to work on numerous aspects of the process and business. As a Senior IT Business Analyst, a typical day might include the following: • Working closely with IT management and business partners to elicit requirements and document processes in support of delivering new business capabilities • Partnering with a diverse business community to document as-is and to-be business processes • Documenting clear and testable requirements which describe a system to be implemented • Collaborating in the creation, review and approval of validation documents • Recommending...
Regeneron Pharmaceuticals, Inc. East Greenbush, NY, USA
Jul 25, 2021
Full time
Summary: Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs. *Please note that this will be a 1st shift position (6:00 a.m.-4:30 p.m.,) and 2nd shift (2:00 p.m. -12:30 a.m.) Essential Duties and Responsibilities include, but are not limited to, the following: • Assists and/or contributes in all areas of production as needed. • Includes all aspects of biotech production activities related to cell culture • Monitors production processes including cell culture and purification activities for drug substance manufacturing and filling, and inspection and packaging activities for drug product manufacturing. • Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure. • Ensures availability of production batch records for upcoming lots. • Performs manufacturing-level maintenance and cleaning of equipment. • Participates in...
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Jul 25, 2021
Full time
Regeneron is currently looking for a Quality Control (QC) Raw Materials Administrator with a Monday-Friday, 8am-4:30pm schedule. Our QC Raw Materials Administrators provide support to the Quality Control raw materials group to ensure all testing and activities are in compliance with cGMPs and Regeneron's internal procedures and policies. As a QC Raw Materials Administrator, a typical day might include the following: Representing Quality Control Raw Materials for compliance and technical support of Deviations, including active participation in investigation, evaluation, and problem resolution Providing compliance and technical support for deviations, investigations, and laboratory activities Initiation and management of Change Controls, CAPAs, etc. for QC Raw Materials documentation and procedure creation and revisions Manages and supports QC aspects for new raw materials to be used in manufacturing (documentation generation, material qualification, method development, etc.)...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 25, 2021
Full time
We are looking for an experienced IT/OT Specialist to lead and drive several key functions within the IT department. These functions will enable the delivery of a high-quality service to OT end users and accelerate the strategic Security and Compliance posture of the IOPS (Industrial Operations and Product Supply) Operational Technology (OT) security program. You will contribute as a domain expert to technical design, implementation and support of OT cyber security solutions and OT standard methodologies within strategic IOPS sites. Our team works within the IOPS IT/OT team and liaises with other cyber security, Networking and IT teams and technically contributes to ensure industrial sites are secure and aligned with company requirements. As a Principal IT Operational Technology Specialist, a typical day might include the following: Leading the delivery of IT/OT solutions; identifying vulnerabilities; advising management and/or business owners of critical issues. Ensuring the...
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Jul 24, 2021
Full time
We are currently recruiting for a Sr. Process Specialist who will be responsible for providing technical direction and resolution for issues on and off the production floor for aseptic, cell culture, or purification manufacturing. The successful person would be a key member of the large scale manufacturing program. As a Sr. Process Specialist, a typical day might include the following: • Provides technical input to resolve process issues both on and off the production floor. • Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites. • Supports NOE's, EOE's & CAPA implementation on process investigations. • Supports onsite educational programs to improve technical competence of manufacturing personnel. • Supports all aspects of the aseptic, cell culture, or purification manufacturing process according to approved protocols, regulation, and schedule. • May contribute to the technology transfer of the manufacturing process. •...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 24, 2021
Full time
Summary: We are currently looking to fill a Drug Product Engineer position within our Drug Product Manufacturing Science and Technology team. This position will support equipment selection, CMO selection strategy, management of equipment qualification activities, and will be hands-on solving issues during technology transfer and cGMP start-up. The team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. The position will also focus on ensuring site to site consistency after the processes are successfully transferred. The Engineer will also provide floor support during operations of off-site manufacturing, review process data to ensure operational consistency and provide support for investigations. In this role, a typical day might include the following: Providing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution With the support of cross-functional teams, acting as...
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Jul 23, 2021
Full time
Regeneron is currently looking for a Quality Control (QC) Analyst with a 1st shift, Sunday-Wednesday, 6am-4:30pm schedule. This position is part of our QC Chemistry- Day 1 team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC Analysts are on the front line, performing chemical tests on these life changing products to ensure that they are safe for our patients. They perform all testing that is required by an approved specification for both clinical and commercial manufacturing products, which helps to ensure that our drugs are safe and efficacious before use. As a QC Analyst , a typical day might include the following: Following Standard Operating Procedures to perform routine testing of Release, Stability, and in-process drug samples Provide support to the manufacturing process by completing urgent testing and data review with very tight...
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Jul 23, 2021
Full time
Regeneron is currently looking for a Quality Control (QC) Analyst for QC Sample Management department with a 2nd shift schedule, Sunday-Wednesday, 1-11:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Quality Control's role is to ensure product quality and patient safety. Our QC Sample Management department acts as the gatekeepers of QC, accessioning and triaging samples as they are submitted for testing; the QC Analyst position performs a variety of sample receipt functions as well as sample preparation requiring the use of a Laminar Flow Hood and pipettes. As a QC Analyst in Sample Management , a typical day might include the following: Verification of sample submissions to Quality Control Receipt of samples and documentation of transactions in Laboratory Information Management System (LIMS) Handling, storage, and organization of samples...
Regeneron Pharmaceuticals, Inc. New York, NY, USA
Jul 23, 2021
Full time
The Senior Manager Sourcing COE, will develop, maintain, and facilitate the company-wide application of process, practice, tools, systems, and competencies to support effective Supplier Management (SM). This encompasses performance management and relationship management practices. This key role will act as a key enabler who actively works with sourcing function partners to continuously improve and enable the effective and efficient use of Supplier Management capabilities within the organization. We are seeking someone who will support effective implementation of Category Management (CM) practice and serve as SME. A typical day may include the following: Support and champion the development and improvement of SM/CM procedures, guides, tools, and templates. Actively advocate project management principles/techniques which improvement and support change management activities for the department. Leads and/or works with others to solve issues of diverse scope where analysis requires...
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Jul 23, 2021
Full time
The Director of RA CMC will provide strategic management and leadership to support the Regeneron portfolio of products assigned. Specifically, this new role will include CMC regulatory leadership on gene therapy products. The candidate will be responsible for assuring development and execution of regulatory strategies for drug products and combination products in the US & EU and lead the activities of other CMC regulatory affairs staff or contract regulatory support in the performance of the duties outlined below. In this role, a typical day might include the following: Responsible for leading activities of assigned Regulatory Affairs CMC team with emphasis on global regulatory strategy and the preparation, review and submission of documents for FDA and other regulatory authorities. Supports the regulatory function on assigned development/commercial programs providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks. Critically...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 22, 2021
Full time
We are currently looking to fill a Project Manager, Quality Assurance position. This position works with cross-functional teams to establish the foundation for new external business relationships within QA at Regeneron. In this role, a typical day might include the following: • Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external) • Maintaining compliance with Regeneron and global Regulatory standards and helping to establish standards where needs have been identified • Assessing process/system effectiveness and efficiency • Monitoring Process Performance over time • Ensuring systems are fully implemented and coordinated with other quality management systems • Developing and providing tools to enable system understanding across multiple organizations • Leading continuous improvement initiatives based on user feedback and process monitoring results • Authoring and revising SOPs • Assisting as needed in audits and inspections •...
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Jul 22, 2021
Full time
Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our managers in Quality Control (QC) oversee the laboratory quality control testing of in-process, stability, and final drug products. As a Manager in the Quality Control Department a typical day might include the following: • Coordinate with members of Manufacturing, R & D, and Formulation to provide analytical support. • Perform personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations. • Supervise QC Analysts, distribute work load, and monitor progress. • Review test reports. • Attend meetings to keep informed of manufacturing priorities. • Ensure compliance with applicable cGMP regulations and SOPs, and safety standards are maintained. • Investigate atypical test results as necessary. This job might be for you if: • You...
Regeneron Pharmaceuticals, Inc. Troy, NY, USA
Jul 22, 2021
Full time
We are currently looking to fill a Senior QA Validation Specialist position. This position will validate and qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. In this role, a typical day might include the following: • Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria • Analyzing the results of testing and deciding the acceptability of results against pre-determined criteria • Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements • Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation This role might...