160 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...

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...

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....

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...

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...

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...

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...

Regeneron is currently looking for a Quality Control (QC) Analyst for our QC Raw Material Utility laboratory with a 1st shift, Monday-Friday, 6am-2:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC raw material utility laboratory performs testing of the raw materials used in the manufacturing process. Various raw materials are tested in the laboratory using manual or instrumentation testing procedures.     As a QC Analyst, a typical day might include the following: • Train other employees on laboratory activities • Utility (water/gas) testing • Data review • Perform laboratory investigations • Write / revise laboratory related documentation (e.g. SOPs, SPECs) • Maintain laboratory supplies • Ensure continuous laboratory compliance to cGMP requirements (e.g. Laboratory cleanliness, equipment within calibration, proper...

Regeneron is currently looking for an Analytical Specialist position with a 1st shift, Monday-Friday, 8am-4:30pm schedule. This position is part of the Analytical Sciences Chemistry Method Development Team. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product through Process Validation. This position will be responsible for development and troubleshooting of chromatography and spectrometric-based assays utilized in Quality Control testing. In this fast pace environment with a strong pipeline, Analytical Specialists have the opportunity to develop scientifically but also gain insight into other areas of the business. As an Analytical Specialist, a typical day might include the following: Work cross-functionally to bring new assays into the group from our research groups. Design and execute assay development experiments to...

ROLE SUMMARY   Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.       All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues can grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and can impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.   Pfizer is advancing in Neuroscience, and...

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:...

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.  The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.  This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Contributes and drives ongoing process improvement initiatives.  This role has a 3-day onsite minimum requirement at either Basking Ridge, NJ, Armonk, NY, Uxbridge, London, or Dublin, Ireland. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and...

This role is a hybrid position which requires a minimum 3 days on-site in Basking Ridge, NJ or Armonk, NY. Remote work is not an option for this role. The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and...

This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment,...

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.  The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.  This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Contributes and drives ongoing process improvement initiatives.  This role has a 3-day onsite minimum requirement at either Basking Ridge, NJ, Armonk, NY, Uxbridge, London, or Dublin, Ireland. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and...

Summary As an Associate Director of Publications Management, you will lead cross-functional publication teams to develop, manage and implement the publication plan of one or more therapeutic areas. You will build and update publication plans, and provide summary reports to partners. Job Duties A typical day may include the following: Leading cross-functional publication teams with company partners to develop, manage and implement the strategic medical publication plans in Hematology. This will involve the timely and efficient development and submission of manuscripts, abstracts, and meeting presentations. Guide and have oversight of publication vendors, contract writers and editors, draft budgets, and travel to conferences as needed. Develop a firm scientific understanding of the Hematology therapeutic area; additionally, should possess an understanding of clinical study design, statistics, and pharmaceutical research and development. Familiarity with...

As a Director, Health Economics and Outcomes Research, Immunology you will work with HEOR’s center of excellence and cross-functional partners formulating our strategies, plans and studies. We develop and implement global and regional HEOR strategies and programs to inform, support and strengthen commercialization activities, including clinical development, marketing, and market access This position will require you to be on-site for 3+ days/week at our Sleepy Hollow, NY offices. If eligible, we can offer relocations assistance. We do not have the option for a fully remote position. A typical day may include the following:  •    Collaborate with our Alliance partner on HEOR plans, studies, and projects; build and maintain constructive and positive relationships across Alliance. •    Lead and collaborate with HEOR subject matter experts to develop and implement evidence generation plans supporting clinical development and value demonstration.  •    Partner with cross...

As a Senior Director, HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and commercialization activities for our products within our General Medical area. Drawing on your expertise in epidemiologic study design and methods as well as on your knowledge of real-world data, you will design, conduct, and reporting of real-world evidence (RWE) studies. It is expected to have current epidemiologic methods and work effectively in a cross-functional environment. This is a Sleepy Hollow, NY office-based position with requirements to be on-site for a minimum of 3 days/week. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option for this position. A typical day may include the following: •    Conducting observational research, using large electronic healthcare databases to generate a better understanding of disease and real-world outcomes •    Developing and/or reviewing...

The Senior Medical Director, Obesity Global Medical Affairs provides strategic leadership with high visibility in the organization, reporting into the Executive Director of General Medicine, Global Medical Affairs. The Sr Medical Director orchestrates the development of medical strategy, planning and execution of medical affairs activities at Regeneron with the benefit of the patient at the forefront. They provide strategic planning and execution leadership by thoroughly understanding relevant the disease, ongoing development programs, market dynamics, as well as priorities and serve as a scientific and medical resources. The Senior Medical Director leads a multifunctional Medical Impact Team (MIT) within a matrix organization, consisting of colleagues within the medical affairs organization. They ensure alignment working closely with research & development, commercial, access & reimbursement, and patient advocacy colleagues and represents Regeneron towards collaborators...

Regeneron is a global leader and pioneer in ophthalmology research and has market-leading drugs for the treatment of retinal diseases. The Eylea brand is approved for the treatment of several retinal disorders and is the market category leader in the anti-vascular endothelial growth factor (anti-VEGF) class for these disorders. Beyond Eylea, Regeneron is committed to research with other mechanisms of actions and modalities for the treatment of a variety of other ophthalmological disorders. Regeneron Global Medical Affairs is organized in an optimally aligned matrix structure for the delivery of therapeutic and functional area expertise. Our medical affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. They serve as important contacts between Regeneron and the scientific and healthcare community. The Head of Medical Affairs for Ophthalmology will report to the Head of Internal Medicine for...