35 legal jobs found in Rensselaer, NY

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...

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 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 a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron’s Data Governance systems and practices meet the highest standards of regulatory & industry compliance. The post-holder is responsible for providing specialized knowledge and expertise in the design of Data Governance (DG) frameworks, policies & procedures that are aligned with regulatory requirements and industry standards.     In this role, a typical day might include the following:   Assess current and evolving regulatory guidance & industrial intelligence in relation to IOPS business practices.   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices . Technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and that the...

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...

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 Manager, Global Procurement – Facilities & Capital Equipment, will report to the Associate Director, Global Procurement – Facilities, Capital & Logistics (FC&L) and is responsible for developing and driving strategy for our responsible categories such as facilities services, capital equipment, and construction. They work collaboratively with teammates as well as cross-functionally with partners across all Regeneron campuses. The Manager owns supplier relationship, actively participates in supplier selection, and manages ongoing performance and service delivery. A Typical Day may include: Leading and collaborating with others to solve issues of diverse scope and provide analysis considering current business trends Continuous Improvement projects to improve efficiency and produce high quality work Negotiating internally and externally to get the best value for Regeneron Drafting and negotiating contracts (regional/global), while working with internal legal...

The Data Governance (DG) ECM champions a culture of data governance within their site by ensuring compliance with DG policies; crafting and delivering relevant training; and monitoring DG practices. The role is pivotal in promoting data stewardship, improving data quality and ensuring DG principles are embedded in the site culture. As a Senior GMP Data Governance & Engagement Specialist, a typical day might include the following: Working in conjunction with the Global DG (Policy & Programs) Team to craft & deliver continuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs. This includes: Crafting, developing & delivery of comprehensive training programs focused on DG, compliance with regulations, and standard methodologies for bio-pharmaceutical manufacturing while using e-learning platforms, simulation tools, and virtual training environments Assess industry trends and regulatory updates on training needs and...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics...

Job Description Summary Job Description We are the makers of possible    BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.  Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical...

Work Flexibility: Field-based Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Our mission Together with our customers, we are driven to make healthcare better. What you do As a sales representative in our Sports Medicine specialty, you’ll be the face of Stryker products. Acting as a sales lead, you’ll prepare and...

Work Flexibility: Field-based Trauma Sales Associate   About the Role   As a Trauma Sales Associate, you will work with a high degree of intensity and commitment to support sales of Stryker Trauma products that meet our customers’ most pressing needs. Under the supportive supervision of a Trauma Sales Representative, you will gain exposure to the proven winning Stryker Trauma team culture that delivers industry-leading results. You will receive best-in-class formal training on our Trauma product portfolio and sales methodology .  This includes on-the-job training in the operating room. You will become an expert on surgical procedures by observing well-over 300 medical procedures in your first year. You will develop a high level of competency in orthopedic surgical needs and procedures and become a valuable member of the surgical team who positively impacts surgical outcomes. You will be comfortable being on call most nights and...

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...

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...

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...

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas....

Career Category Sales Job Description Territory covers > Bronx, NY; Westchester, NY; West Nyack, NY; Stamford, CT HOW MIGHT YOU DEFY IMAGINATION? At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is...

Work Flexibility: Field-based Who we want Hard-working winners. Committed, loyal and results-oriented salespeople who create a track record of success. Persuasive influencers. People who understand market positioning and can use their relationship skills and depth of knowledge to secure buy-in, cooperation, and loyalty. Organized self-starters. Salespeople who create and maintain precise inventory control to ensure they can initiate the implementation of a solution with the proper product or tool. Mission-driven salespeople. Fiercely intense representatives who work whatever hours necessary to live out their purpose of changing people’s lives and making healthcare better. What you will do The Upper Extremities Sales Associate will partner closely with Sales Representative(s) in the area to quickly learn the medical device industry and Upper Extremities business, and then contribute to the growth of that business in the assigned territory.   He/she will...

Work Flexibility: Field-based Associate Sales Representative (Joint Replacement) As a Joint Replacement Sales Associate, you work as part of a sales team learning and honing your sales skills. You support the marketing and sales of Stryker products by covering cases and performing evaluations in both surgical and office environments. You monitor territory development and maintain clear communication with the sales team. Our mission-driven Associates will be a part of delivering outstanding customer service by assisting the Sales Representative to surpass sales targets and performance benchmarks. What you will do: · Assist in promoting and selling Stryker products. · Conduct product evaluations in Operating Room (OR) and office settings. · Track territory progress and communicate effectively with Sales Representatives. · Solve product problems onsite and educate medical staff. · Provide exceptional service to customers. · Manage and maintain sample inventory...