108 jobs found in Albany, 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...

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...

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...

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...

We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification passionate about immunohistochemistry (IHC) and lead implementation and execution of CDx assays (from study conduct, sample management testing to launch) in collaboration with partners/IVD Sponsors and central testing laboratories to support early and late-stage programs within our oncology pipeline. As a Director, a typical day may include the following: Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs Develop strong relationships partnerships with IVD partners and testing...

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 Associate Director, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to provide strategic oversight of laboratory deliverables across the portfolio, ensuring that study start timelines are met , provide risk management. Collaborates with stakeholders for all aspects of clinical laboratory deliverables (from study conduct, sample management testing to launch). This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.   As an Associate Director, a typical day may include the following:...

The Senior Director, Precision Medicine Strategy Lead role is critical for the successful execution of Regeneron biomarker strategies. Will be accountable for leading a team responsible for overseeing the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. This is a strategic role responsible for independently designing, developing, communicating at senior levels and overseeing the implementation of clinical biomarker strategies across key programs in early and late stage drug development. Further, this role is responsible for providing subject matter expertise to drive successful relationships with both internal groups at Regeneron as well as external KOLs. Oncology programs comprise nearly half of the overall growing Regeneron development portfolio, including novel modalities, targets and combination therapies. This role has a 3-day onsite minimum requirement in Armonk, NY or Basking Ridge, NJ. As a...

This is a hybrid position that requires 3 non-consecutive days on-site in Armonk, NY or Basking Ridge, NJ, and 2 days from home. A fully remote role is not possible for this position. The Associate Director, Strategic Facilitation will objectively lead discussions or workshops ensuring business objectives are reached efficiently and effectively. The Associate Director, Strategic Facilitation will help individuals and groups identify their purpose and articulate key actions they must take to ensure they realize their purpose, designing each experience utilizing tools and methodology that suits the required challenge, issue, and outcome. The Associate Director, Strategic Facilitation will project manage workshop outcomes as needed. The Associate Director, Strategic Facilitation will support the Director in the creation and leadership of a facilitation center of excellence and Community of Practice. In a typical day, you will: Design and manage complicated engagements that...

This is a hybrid position on-site 3 days per week in Armonk, NY or Basking Ridge, NJ and 2 days from home. A fully remote role is not possible for this position. The Senior Director, Transformation Program Management will play a vital role in the planning, execution and delivery of cross-functional and complex non-drug strategic and transformational initiatives for Global Development and other areas of Regeneron as requested. This role will collaborate closely with senior and executive leaders and stakeholders to drive the business transformation across the organization. The Senior Director Transformation Program Management communicates and collaborates with executive stakeholders and customers to ensure alignment and satisfaction. This role consults and negotiates with the Director Business Transformation Lead and Director Transformational Change & Engagement to translate business objectives into programs of work to be executed upon. This role requires a visionary leader...

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...