34 executive jobs found in Rensselaer, NY

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 Sr/ Executive Director, GMP Data Governance & Integrity position. This position is responsible for the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program. Directs and leads the activities of team. Works closely with business leaders and department subject matter experts to implement data integrity standards into business operations. Serves as the global leader on good practices for their area. Develops and delivers effective training and education programs; works with the business to embed practical steps into procedures, processes and other documentation. In this role, a typical day might include the following: Business Priorities: Global owner and lead for Data Governance and Integrity – defines the standard and ensures broad understanding and integration across the business Partners with personnel to define or revise associated business processes to meet defined standards; applies...

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 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 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 Director of IT Operations position. This position ensures the reliable operation of the IT infrastructure and operations portfolio. This role involves supervising, planning, coordinating, directing, crafting, and delivering activities of the IT operational staff primarily in the GxP environment. The Director provides administrative direction and support for daily operational activities of the department, including responsibility for all hardware and compute / communications infrastructure, also, ensuring integration and coordination with Corporate systems and infrastructure. In this role, a typical day might include the following: Responsible for driving and delivering work plans, providing technical direction to IT operations staff, and delivering technology solutions to end users. Works closely with decision-makers in other IT Automation and manufacturing departments as well as Corporate IT to proactively identify, recommend, develop,...

We are currently looking to fill a Director of GMP Data Governance position. This position acts as a link between global policy and standard setting and the local implementation of these within their site business unit(s). It plays an integral part in safeguarding the quality and reliability of the organization’s data which is critical for informed decision making and regulatory compliance. The position requires a blend of technical knowledge within the biotech or pharmaceutical sector, coupled with positive relationship building and analytical thinking skills. In this role, a typical day might include the following: Building, leading & managing of the site Data Ops & Engagement, Culture & Monitoring (ECM) team & the delivery/implementation of site DG responsibilities & standards. Successful collaborator engagement & management across the site. Establishing a successful relationship with the global Governance Team (Policies & Programs) so a...

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...

The Screening Team is a dedicated organization inside of Guardant Health focused on the development and commercialization of the early cancer detection portfolio. The Screening Team’s singular focus on bringing our early cancer detection products to market allows us to act with the speed and urgency needed to achieve our ambitious goals and serve the millions of individuals who can benefit from early cancer detection.  About the Role:   The field-based Regional Sales Director is responsible for leading a team of Account Executives within a designated region. The Regional Sales Director (RSD) is responsible for the effective promotion of SHIELD to general practice providers and their practices within the designated area.  The Regional Sales Director will recruit, hire, coach, develop, and lead the Account Executives for the launch and promotion of SHIELD.  Responsibilities:   Prospect and target to identify a region early adopter list and generate adoption of SHIELD....

Regeneron is currently seeking an Associate Director to join our Downstream Sciences and Investigations (DSIG) team. The Associate Director- Process Sciences leads a lab based team responsible for the assessment of changes to raw materials and their impact to Manufacturing operations and product quality. The role also maintains awareness of industry and regulatory trends to manufacturing technologies and material sciences to assess and support implementation within IOPS to remain in the forefront of industry.   As an Associate Director- Process Sciences a typical day may include: Leads cross-functional teams in generating and analyzing data to assess raw material attributes for impact to new and existing manufacturing processes which include change notifications, secondary sourcing, raw material investigations, and impurity/byproduct/extractable risk assessments. Perform risk assessments for changes to raw materials to determine potential impact to the processes. Leads...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Reporting to the Regional Sales Manager, the Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the...

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 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...

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....

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 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 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...

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst with a 3rd shift, Wednesday-Sunday, 10pm-8:30am schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Microbiology Analysts perform microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will be primarily responsible for performing routine environmental monitoring for aseptic fill/finish manufacturing areas, utilities sampling and testing, , gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing. As a QC Micro Analyst, a typical day might include the following: Environmental monitoring of controlled environments, personnel and...