99 jobs found in Rensselaer, NY

The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to identify trends through metrics in order to diagnose and remediate systemic quality issues. In this role, a typical day might include the following: Responsible for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML Engage with, support and liaise with multiple cross-functional collaborators whose work impacts the...

The role of Senior Manager, Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD, etc.) within Regeneron’s drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, program/project management and operational execution of complex diagnostic strategies to support clinical programs across a variety of therapeutic indications. The successful candidate will work cross-functionally within Diagnostic team, Precision Medicine and other functions internally to anticipate and meet the needs of these programs as well as ensure seamless delivery to milestones. Additionally, this role will serve as a key point of contact with external diagnostic partners, laboratories and vendors required to support development and delivery of the diagnostic strategies. As a Senior Manager, a typical day may include the following:...

We are seeking a highly motivated Senior Manager, Business Operations Cost Management, who will be responsible for cost management activities regarding running clinical trials.   The Senior Manager, Business Operations Cost Management, will work at the portfolio, program and functional levels to provide prospective and retrospective measurements of cost, productivity, efficiency, and quality to facilitate informed decision making for Regeneron’s clinical development portfolio.  The Senior Manager, Cost Management will act as a business partner providing critical business operations support to GD, Development Operations & Portfolio Management (DO&PM) functional leadership, Procurement and Finance. This role has a 3-day onsite minimum requirement in one of our office locations. This role is NOT eligible fully remote. Relocation assistance will be provided to those who qualify. A typical day in this role as a Sr Manager looks like: Understand how CROs apply...

The Project Manager provides support for complex cross-functional strategic projects as directed by Senior Project Managers or Program Managers. The Project Manager will support driving and delivering results per charter goals, managing scope, schedule, quality, resources, risk and value/ benefit.  The Project Manager will also manage medium to small projects independently for the business or internal to the function with oversight by more seasoned Program/Project Managers or leadership. A Typical Day Might Look Like this: Plan, manage, execute and deliver a project through its lifecycle within the approved scope, schedule and budget  Secures acceptance and approval of deliverables and perceived value from the Project Lead and Stakeholders  Estimates and coordinates project resources  Maintains the Project Charter, schedule, issues log, budget and risk management plan Manages the risk register and the escalation of risks and issues. Partners with Change...

This is a hybrid position on-site a minimum of 3 non-consective days in Tarrytown, NY or Basking Ridge, NJ is required. A fully remote role is not possible. We are seeking a highly experienced and dynamic Senior Director Development Project Manager to join our team. The successful candidate will primarily be responsible for identifying and developing a team of manager through associate director ready program managers.  Additionally, the successful candidate will provide operational leadership, direction, and support to assigned small and/or low to medium complexity development program(s). This is a new leadership role within the department that requires strong people management and talent development skills, strategic thinking, excellent leadership skills and a proven track record in project and program management within the biotechnology or pharmaceutical industry. In a typical day, you will: Recruit, hire, build and lead a team of high performing, early-career program...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities...

With guidance, an Associate Manager, Drug Development Program Management (DPM) uses program management knowledge and experience in the drug development industry to provide operational leadership and manage components of development program(s). You will contribute to the cross functional development team (Strategic Program Team) to develop strategic plans including goals, budgets, timelines and track the execution of these plans from preclinical through commercialization/lifecycle management.  This role has a 3-day onsite requirement in either Tarrytown, NY or Basking Ridge NJ. This role is not eligible to fully remote work. A typical day as an Associate Manager in DPM looks like: Project Planning and Execution: Assist in the development and maintenance of integrated project plans, timelines, and budgets for drug development programs. Plan, track and manage project milestones, dependencies and critical path through existing project management planning systems and...

Using prior program management knowledge and experience in the drug development industry, the Sr. Manager Development Program Management provides operational direction as the leader for one or more development programs [within a given Therapeutic Area]. The Sr. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated [project] program plans, goals, budgets, and timelines.   The Sr. Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers. A typical day as a Sr Mgr in Development Program Management looks like: SCOPE: Supports development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development...

A Manager, Development Program Management (DPM) uses program management knowledge and experience in the drug development industry to provide operational leadership and manage components of development program(s).   This individual contributes to the cross functional development team (Strategic Program Team) to develop strategic plans including goals, budgets, timelines and track the execution of these plans from preclinical through commercialization/lifecycle management.   A typical day as a Manager in DPM looks like: Development Teams: Under the direction of their manager or DPM Lead, supports select subteam and/or functional area meetings. May lead functional area and/or working group meetings.  Participates in development of risk management plans.  Tracks deliverables, risks, and issues. Business Acumen:   Under direction of their manager or DPM Lead, Identifies stakeholders across organization to facilitate cross functional reviews/alignments of key...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities within...

The Manager, Vendor & Relationship Management (VRM) provides support to the operational requirements for which VRM has accountability to ensure optimal functionality and business operations within VRM along with support of the overall delivery of the Vendor Engagement life cycle.    This position will have key interactions with partnering functions within REGN as well as with external partners. ​Leads, on behalf VRM, the document collection and analysis of Governance and Oversight Compliance. A Typical Day Might Look Like this: Manage and document the tiering of Global Development Vendors in collaboration with VRM staff and relevant functions Measure and manage the application of Partnership Effectiveness framework and behaviors across Global Development Support generation and continuous improvement of VRM metrics, including additional support needed to each Segment on applicable Vendor/segment specific dashboards Leads and oversees the creation,...

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...

We are currently looking to fill a Supervisor Quality Assurance (Batch Record Review) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Providing consultation or advice in alignment with QA policies Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk Reviewing, editing, or approving Regeneron controlled documents Reviewing and approving of investigations associated with raw materials, product, laboratory,...

We are currently looking to fill a Supervisor, Document Control position. This position will provide support to the Rensselaer site related to documentation system and ancillary support systems. This individual would also lead a team of document control professionals. Shift Available: 3rd Shift, Sun-Wednesday, 10pm-8:30am In this role, a typical day might include the following: Prepares status reports for management Coordinates review and revision of controlled documents Counsels employees about work performance, leads monthly review sessions and handles their trainings As appropriate, trains staff and user departments in documentation systems and provides guidance for proper use of the document change systems to ensure consistency of system usage Reviews and approves administrative changes to controlled documents for Quality Assurance Coordinates document requests and stages documents for presentation during regulatory inspections Implements and...

The Senior IOPS IT Project Manager will be responsible for delivering complex and strategic IT projects across Applications and Infrastructure for IOPS. Essential Duties and Responsibilities include, but are not limited to, the following: Provide project management and/or business analysis support for the development and implementation of assigned IOPS IT Systems; previous experience using Microsoft Project is required. Work with business owners and key stakeholders to develop project scope, goals, deliverables, required resources, budgets, and timing. Manage and own project delivery within budget, scope, quality and time requirements. Ensures project documents are complete, current, and stored appropriately e.g. Project Charter, Project Plan and Resource Plan etc. Manage day-to-day client interaction and expectations for one or more small to medium scale projects. Create and executes project work plans and revises as appropriate to meet changing needs and requirements....

Within this role you will be a vital part of the IOPS IT Business Operations function supporting core business services such as Communications Management, Resource Management, Organizational Change Management and Procurement Support. As an IT Business Operations Analyst, a typical day might include, but is not limited to, the following: Generating content and coordinating IOPS IT communications Helps develop and maintain IT communication policies, procedures, and guidelines to support the increased visibility of IT across IOPS Supports development of IOPS IT presence on the Regeneron Intranet; SharePoint web page development and content management for the IOPS IT SharePoint intranet sites/pages Provides engaging content for existing site communication channels, including production of IT Business Operations updates & IT Newsletters Works with the IT Business Operations team in updating the relevant communications platforms, dashboards and metrics to ensure...

We are currently looking to fill a Supervisor, Document Control position. This position will provide support to the Rensselaer site related to documentation system and ancillary support systems. This individual would also lead a team of document control professionals. Shifts Available: 1st Shift: Monday - Friday, 10am-6:30pm In this role, a typical day might include the following: Prepares status reports for management Coordinates review and revision of controlled documents Counsels employees about work performance, leads monthly review sessions and handles their trainings As appropriate, trains staff and user departments in documentation systems and provides guidance for proper use of the document change systems to ensure consistency of system usage Reviews and approves administrative changes to controlled documents for Quality Assurance Coordinates document requests and stages documents for presentation during regulatory inspections Implements and...

The Supply Chain Process Excellence team implements the strategic direction as set by leadership, to improve the global capability and increase process efficiency in all areas of Supply Chain including, but not limited to, Supply & Demand Planning, Warehousing, Transport & Trade, Inventory Management and Reporting. The role combines project management expertise with continuous improvement methodologies to drive the efficiency and effectiveness of E2E Supply Chain processes. A typical day might include the following: Lead high priority projects, provide strategic direction, and ensure alignment with organizational objectives, working cross-functionally to implement best practices and manage deliverables. Partner with the Senior Director SCO to Identify opportunities for cross-functional improvements through people, processes, and infrastructure, tailored to specific situations. Partner with Operations Leadership Team (OLT) to maintain alignment of supply chain...

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...

We are currently looking to fill a Manager, QA (Supplier Quality) position. This position coordinates the Quality Assurance initiatives for a broad range of topics relative to material and supplier quality including Supplier Management and Material Qualification. This role also supervises a team of Material Supplier and Compliance Specialists.   In this role, a typical day might include the following: ·        Accomplishes material and supplier quality objectives through team members and by planning and evaluating area activities. ·        Track status of quality records including document workflows (SOPs, material specifications, etc.), change controls, deviations, CAPAs, extensions, and SCARs. ·        Defines and implements quality standards, systems, and metrics for clinical and commercial operations. ·        Preparing and completing action plans while implementing productivity and quality. ·        Resolving problems,...