65 management jobs found in Rensselaer, NY

We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work 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 with in compliance. 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. In this role, a typical day might include the following: Compliance Apply strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to sophisticated problems. Lead proactive evaluation and education of site GMP compliance against current...

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...

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 looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

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...

We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team.   This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist, Quality Assurance, a typical day might include the following: • Acting as Regeneron’s representative in meetings with external Partners to discuss changes for applicable products • Participating in internal cross functional teams on global change management of partnered products • Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures • Developing relationships with end users and providing advice on best...

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

We are currently looking to fill a Principal Quality Compliance Specialist to join the Quality Assurance Change Control Business Process Team. The Quality Compliance Specialist ensures adherence to cGMPs , internal, external, and international requirements with respect to change control activities. This role is integral to facilitating process improvements, ensuring robust training for system end users, and supporting the Quality Management System.     As a Principal Quality Compliance Specialist, a typical day might include the following:   Developing and executing a comprehensive training strategy for the change control quality system.   Leading training for end users of the Change Control System.   Partnering with counterparts to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process and associated procedures.   Sponsoring and advocating for...

Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions. This position would focus on initial commercial applications, completing the CMC aspects (e.g., Module 3) of submission content.   As a Staff CMC Regulatory Sciences Specialist. a typical day might include the following: Develop processes and tools for the preparation of global marketing applications & support the development and execution of CMC regulatory strategies for global markets. Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local regulations and guidelines. Develop and maintain relationships with cross functional teams, contract manufacturing organizations, as well as global regulatory partners....

We are currently looking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise. Current Department with Openings: Manufacturing In this role, a typical day might include the following: Craft business plans to independently advances change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change Review, edit, and revise controlled documentation in accordance with cGMP standards Coordinate and/or lead cross-functional meetings...

The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. A typical day might include the following: Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supply Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes Support the regulatory submission forms to support regulatory release and QP certification. Foster strong communication and working relationships between IOPS and Global Development Keeps management and all stakeholders informed of assessments, overall strategy, and project status Works within the procedures and systems for enhanced tracking of global regulatory submission packages and approval status....

We are looking for an Ultra-Pure Water (Clean Utilities) Technician with a Wednesday – Saturday, 2:00pm – 12:30am schedule to join 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 Clean Utilities Technicians support the manufacturing process through involvement with start-up, operation, monitoring, maintaining and shutdown of clean utility systems and equipment within Clean Utility mechanical rooms. Please note this will be a Monday-Friday 1st shift 8:00am-4:30pm position for approximately 3-6 months for training. Working hours thereafter will be 2nd shift 2:00pm – 12:30am Wednesday - Saturday. As a Clean Utilities Technician, a typical day might include the following: Performing preventative and predictive maintenance on related clean utilities and systems that support manufacturing. Maintaining water rooms and related...

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...

We are looking to fill a Principal IT Business Analyst position to join our expanding IT team. We drive the business forward by delivering new digital capabilities and technologies. Our Principal 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, Principal IT Business Analysts have an opportunity to work on numerous aspects of the process and business. As a Principal IT Business Analyst, a typical day might include the following: Works closely with IT management and business partners to elicit detailed requirements and document value streams and processes in support of delivering new business capabilities; Partners with a diverse business community to document complex and cross-functional as-is and to-be business processes and identify gaps between them; Documents clear and testable functional and non-functional...

The successful candidate will join a dynamic and high-performing Internal Communications team that thinks strategically and executes at a high level to support our fast-growing company -- where colleagues are passionate about their work and our mission to bring important new medicines to patients in need. Internal Communications is part of the Corporate Affairs organization, which is focused on strengthening Regeneron’s reputation by developing strategies and programs that (1) distinguish our science, medicines and patient focus, (2) sustain culture and drive employee engagement, and (3) advance and differentiate our corporate responsibility commitments. This role will report to the Senior Director, Corporate Communications supporting the Industrial Operations and Product Supply (IOPS) business. This person will collaborate with IOPS leaders and their teams on key functional internal communications strategies and lead their execution to support achieving functional and...

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

We are currently looking to fill an Associate Director/Director Investigations (Quality Control) position. This position is responsible for providing direction and oversight to the review, approval and management of investigations and corrective and preventive actions. In this role, a typical day might include the following: Leads a team with direct oversight of review and approval for GMP Documents May review, verify and approve system records Collaborates cross functionally to provide succinct support to teams to strive to quality outcomes May approve and review Policy/SOP revisions Provides direction for cross-functional teams. Serves as an escalation point as well as determination when additional escalation is required Identify leading practices and recommend improvements to continuously improve compliance profile Serves as a subject matter authority (SME) to present topics to management and during inspections Supervises relevant quality system...

We are currently looking to fill a Process Technician position with a Wednesday-Saturday 6:00 a.m.-4:30 p.m. schedule. 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 compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 6:00am-2:30pm for the first few weeks. Working hours thereafter will be Wednesday-Saturday 6:00am-4:30m 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 Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment Identifying any off-nominal conditions with mechanical equipment and mechanical troubleshooting of...

We are currently looking to fill a Plant Utilities Technician position with a Wednesday-Saturday 6:00am-4:30pm schedule. Our Plant Utilities Technicians are responsible for start-up, normal operation, monitoring, maintaining and shutdown of Plant Utility systems and equipment within Plant Utility mechanical rooms that support overall facility buildings. Please note training will be Monday-Friday 7:00am-3:30pm for the first few weeks. Working hours thereafter will be Wednesday-Saturday 6:00am-4:30pm. As a Plant Utilities Technician, a typical day might include the following: Maintaining high pressure steam and hot water boilers, controls and associated equipment Maintaining boiler and cooling tower chemical treatment program Maintaining all other Plant Utility equipment such as boiler pretreatment water, condensate return, natural gas, domestic potable water, tepid water, wastewater Monitoring controls of plant systems using Building Automation System (BAS) or...