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7 science jobs found in Rensselaer, NY

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Nov 09, 2024
Compliance Specialist - Process Sciences
regeneron Rensselaer, NY, USA
Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab-based position.  This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory departments through the development of strategic plans to support change management activities and documentation related to implementation and maintenance of process control programs for bulk drug substance / formulated drug substance, drug product, combination product, and advanced therapies manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, our Compliance Specialists have an opportunity to work on countless aspects of the process and business. As a Compliance Specialist, a typical day might include the following: Craft business plans to independently advance change control initiatives to implement lifecycle activities of established manufacturing control strategies in support of Global Process...
re
Nov 09, 2024
Manager Global Procurement - Contract Manufacturing
regeneron Rensselaer, NY, USA
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...
re
Nov 09, 2024
Principal QC Micro Specialist
regeneron Rensselaer, NY, USA
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...
re
Nov 09, 2024
QC Micro Specialist
regeneron Rensselaer, NY, USA
Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...
re
Nov 09, 2024
Director, CMC Industry and Regulatory Intelligence
regeneron Rensselaer, NY, USA
The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia. In this role, you will be expected to develop and implement strategies to translate CMC intelligence gathering into action and influence policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence , a typical day might include the following Provides oversight on the IOPS CMC intelligence program Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout IOPS Monitors and assesses...
re
Nov 09, 2024
Principal External Manufacturing Specialist
regeneron NY, USA
We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...
re
Nov 09, 2024
Innovation Protection Specialist
regeneron NY, USA
Regeneron is currently looking for an Innovation Protection Specialist to join our Process Sciences Drug Product Engineering department. The Innovation Protection Specialist is responsible for managing a portfolio of medical device developments by facilitating discussions and workflows including but not limited to agreements, innovation protection, due diligence and information sharing. As an Innovation Protection Specialist , a typical day might include the following: Develops, implements and manages records of innovation protection strategies for combination product medical device programs, including but not limited to due diligence, conflict of interest protection, and device naming and trademarking. Partners closely with internal intellectual property team to establish and maintain a strong portfolio of devices including but not limited to combination products. Partners closely with internal legal, privacy and governance, IT Security, sourcing and intellectual...
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