67 jobs found in rensselaer

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...

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Biotech Production Specialists are on the front line, producing our life changing products and have a passion for assisting those in need by using biotechnology. They perform all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs. What to look forward to: Competitive Compensation- Regeneron offers highly competitive base pay and employees working premium shifts receive incentive pay, such as shift differential and/or weekend pay. All employees receive equity awards and are eligible for annual performance bonuses. We offer comprehensive health coverage, tuition reimbursement, and qualified employees may receive assistance paying down student loans. Relocation assistance is also available for eligible new hires. Work Life...

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 multiple Quality Assurance Specialist positions. This position performs and leads activities “on the floor” in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Available Work Schedules: Wednesday-Saturday - 1st shift Wednesday-Saturday - 2nd shift Wednesday-Saturday - 3rd shift Sunday-Wednesday - 3rd shift In this role, a typical day might include the following: Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication Train and/or mentor employees, including...

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...

Our 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 an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5...

We are currently looking to fill a QA Inspection Specialist position. This position will support Visual Inspection operations performed at Regeneron’s Internal Fill/Finish facility.  This position will provide floor support during production activities and also contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.     Available Working Schedule: Monday-Friday, 2nd shift (2p-10:30p) In this role, a typical day might include the following: Oversee programs to support Visual Inspection Operations at the Drug Product facility. Ensure that facilities, equipment, materials, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other Regeneron controls. Execute daily operations, including, but limited to: Providing Quality Oversight and...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, and maintaining Regeneron’s sophisticated biopharmaceutical manufacturing processes at our Industrial Operation and Product Supply site and at IOPS contract manufacturing partner sites. As a Senior Automation Engineer (CMO Support), a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering...

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....

Within this role you will be responsible for the configuration, implementation, maintenance, and ongoing support of Labware LIMS system.  As a Senior IT Applications Analyst within Quality Systems a typical day might include, but is not limited to, the following:  Administer, configure, and maintain Labware LIMS software to support laboratory operations Provide technical support to end-users, resolve system issues, and troubleshoot errors related to Labware LIMS and other lab systems. Collaborate with laboratory staff to understand their needs and translate them into Labware LIMS configurations. Lead and participate in LIMS-related projects, ensuring timely delivery and adherence to project goals. Coordinating across business departments and stakeholders, gathering, and implementing enhancement requests across departments  Acting as a Technical SME/Lead on initiatives   Managing system documentation tasks, including converting User Requirement Specifications to Detailed...

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...

We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures. In this role, a typical day might include the following: Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact Identifying difficulties and suggesting alternatives that are aligned with QA Reviewing MES change controls and test plans Working with Technical Trainers to develop QA training plans for MES users Collaborating in the creation, review, and approval of validation documents Reviewing and approving MES recipes, master...

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...