85 jobs found in Syracuse, 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...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

As the Head of Publications (Executive Director) you will lead a team of publication managers and writers. We strive to ensure the quality and timely execution of publication projects while driving innovative approaches enabling broad scientific share of voice.  We will deliver strategic development and targeted delivery of clinical and HEOR global publications across all therapeutic areas. This will be across the life span of our assets in a heavily matrixed and scientifically interdependent environment. We have the need to drive a vision for the future that will involve creating efficiencies, showing tangible impact and measurement beyond traditional metrics and transcend beyond typical channels of communication. This position is located in Sleepy Hollow, NY and will require you to be on-site for a minimum of 3 days/week. We do not have a fully remote option for this position. If eligible, we can offer relocation benefits. A typical day may include the following:...

The Executive Director, Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&pD, and other key functions at Regeneron.  The incumbent is an experienced leader, passionate drug developer, skilled manager and mentor, and an accomplished statistician with a strong ability to communicate technical concepts to non-statisticians.   The Executive Director is responsible for providing critical strategic input to the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams to ensure the successful execution on our pipeline.  The Executive Director drives the development of appropriate phase-specific statistical strategies are developed and implemented, such as...

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...

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...

Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. Our ambition is for our novel, first-in-class treatment for bladder cancer to become the new standard of care and backbone therapy for patients across the non-muscle invasive bladder cancer (NMIBC) disease spectrum. In 2024, our intravesical gene therapy achieved over 1,500 patients treated across the country at most major medical centers and community care...

Position Summary The Business Development Director will play a pivotal role in driving strategic growth and revenue generation for IQVIA’s Market Access Technology and Services (MATS) practice. This leader will be responsible for identifying and capitalizing on market opportunities, cultivating executive-level client relationships, and delivering tailored, tech-enabled solutions that address complex commercialization and market access challenges across the pharmaceutical, biotech, and med-tech industries. This role combines strategic sales leadership, deep industry expertise, and cross-functional collaboration to expand IQVIA’s footprint in the life sciences market access space. Key Responsibilities Drive net-new business development across assigned territories, verticals, or solution suites. Develop and execute strategic account plans to build long-term client relationships and drive revenue growth. Identify and analyze market trends, client needs, and competitive...

Job Title: National Account Director-Vaccines Location: Remote/Field About the Job The Director, National Accounts develops and manages strategic partnerships, high quality B2B relationships, and contractual agreements with Sanofi Pasteur’s high-value customers. Assigned customers and partnerships developed have regional/national scope, significant market impact (both direct and indirect influence) and establish market access (supply and contract/pricing nationally) to Sanofi Vaccines products creating a platform to maximize vaccine sales within all customer segments. This position is a REMOTE role. This position is responsible for achieving/exceeding sales and marketing objectives across the high dollar value/dose volume customers with strategic value within National Health Systems.  Directors, National Accounts are expected to acquire and maintain expertise in brand/segment strategy and tactics, product knowledge, contracting and pricing platforms, membership...

As a Director, HEOR you will formulate strategies of our Health Technology Assessment (HTA) submission packages ensuring implementation. The primary responsibilities are to evaluate relevant HTA decisions, apply key findings to pipeline and marketed products. Additionally, you will develop submissions to HTA agencies securing reimbursement. Location: This position will require you to be on-site a minimum of 3 days/week at our Sleepy Hollow, NY location. We are not able to accommodate a fully remote option. If eligible, we can offer relocation benefits. A typical day may include the following: Partner with cross functional and business partners developing and supporting a compelling product value propositions optimizing access, reimbursement and uptake. Provide strategic input and HEOR evidence to support commercial and Government relations lobbying efforts and legislative initiatives. Work alongside regional partners with key payers, industry associations and medical...

Regeneron is seeking an Associate Director, Sales Forecasting & Analytics to act as a leading business partner to the Commercial functions responsible for supporting financial and operational decisions that may impact product and business unit revenue. In this role you will be responsible for the generation, analysis, tracking and dissemination of the commercial revenue forecasts, analyzing actual sales performance and providing related insights for Regeneron’s marketed and new Oncology products. A Typical Day In The Role Might Look Like: Develop and maintain patient-based forecast model applying a mix of epidemiology, secondary data, and primary market research-based sources resulting in detailed patient flow buildout and all relevant variables to produce and analyze revenue forecasts. Convert assumptions to demand sales units, gross and net sales. Understand and analyze actuals, perform revenue variance analysis to isolate and articulate performance drivers. Work...

The Director, Digital Solutions is poised to be a pivotal role in our digital transformation endeavor.  You will lead the charge in exploring cutting-edge technologies, investment in alliance to co-create and design solution tailored for Regeneron to drive the next wave of innovation. You will identify the most promising use cases across business domains, define hypotheses to test, to develop and plan to solution and deliver.  You will lead our digital innovation portfolio and help shape and implement the digital innovation strategy. This role will work with our global leadership team and program teams on the ground and will navigate the landscape of digital innovation to foster partnerships with other pioneers in the field.  At Regeneron, accelerating our understanding of Science is more than a mission for us. In partnership with Research, Clinical & Manufacturing we build and enable tools and software digital products to help accelerate scientific discoveries and improved...

This Senior Director, Corporate Compliance role is a strategic and dynamic role serving as a Compliance Navigator/Advisor to various areas of the business, with a particular focus on supporting Regeneron’s Global Immunology team. This individual will conduct day-to-day risk assessment and management to help support the vision for Compliance at Regeneron, by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison and primary point of contact for Compliance-related topics to assigned areas of the business, including headquarters and field-based Commercial and Medical Affairs teams. This individual will integrate practical compliance best practices within business processes. In addition, this individual will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify Compliance risks and enhance monitoring opportunities. This individual will be expected to...

This role offers the right candidate an exceptional opportunity to join Regeneron during a time of dynamic growth. With key product launches, pipeline assets advancing in the clinic, and expansion of footprint in international markets, Regeneron is entering one of the most exciting periods in its history. As we expand our Pricing Organization to adequately support Regeneron’s growth, you will play a key role in leading the Pricing Strategy and being a strategic thought partner and subject matter expert for the organization. The Director, Pricing Strategy will serve as the primary point for the Brand on all pricing matters and will be responsible for leading the development and design of Global/US pricing and contracting strategies for a key oncology product. This position will lead the development of Global/US pricing guidance and management of ongoing market price proposal approvals and serve as the subject matter expert on pricing trends and practices. This role requires a...