38 jobs found in Worcester, MA

Purpose: The Account Manager Specialist, Operations Contract Manufacturing (OCM) will be responsible for supporting the biologics contract manufacturing business. The position will be accountable for interactions with customers and general customer support, project management as required, invoicing and tracking of purchase orders. This role will need to understand and manage contracts and contract deliverables for third party programs as well as have a basic understanding of biologics manufacturing. The position will be required to interact with internal stake holders from Manufacturing, Product Development Science and Technology, Quality Organizations, Logistics and Finance departments to ensure the success of the contract programs.  This may entail driving resolutions should issues arise on the programs as well as the coordination of timely communications. Assist with contract extensions and the creation of new scopes of work as required. Responsibilities: Create client...

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...

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...

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 Senior IOPS IT Project Manager will be responsible for delivering complex and strategic IT projects across Applications and Infrastructure for IOPS. Essential Duties and Responsibilities include, but are not limited to, the following: Provide project management and/or business analysis support for the development and implementation of assigned IOPS IT Systems; previous experience using Microsoft Project is required. Work with business owners and key stakeholders to develop project scope, goals, deliverables, required resources, budgets, and timing. Manage and own project delivery within budget, scope, quality and time requirements. Ensures project documents are complete, current, and stored appropriately e.g. Project Charter, Project Plan and Resource Plan etc. Manage day-to-day client interaction and expectations for one or more small to medium scale projects. Create and executes project work plans and revises as appropriate to meet changing needs and requirements....

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...

We are hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure manufacturing documentation a nd implementation aligns with Process Transmittals and meet the requirements of Regeneron’s quality system. In this role, typical day may include: Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Train and/or mentor junior employees, including providing insights and education on processes and procedures. Provides consultation or advice in alignment with QA policies. Review, edit, or approve Regeneron controlled documents. Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement. Responsible...

We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution  Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and polices as well as review of documents for both internal and external transfers Providing consultation or advice in alignment with QA policies Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen) and externally...

We are currently looking to fill a Sr QA Project Specialist role supporting our Change Control Business Process Management team. This position supports the achievement of Quality Assurance (QA) objectives by planning, coordinating and leading project activities. This position manages cross-functional projects as both a facilitator and organizer, using knowledge within the pharmaceutical industry and project management techniques. In this role, a typical day might include the following: Lead cross-functional projects and develop project timelines.   Identify and lead project priorities and cross-project dependencies.   Collaborat e with functional leads/subject matter experts in driving execution and removing constraints that prevent advancement of efforts/projects.   Proactively engag e in activities to meet schedules and resolve issues .   Identify skills needed for project management and deploy and...

The Project Manager provides support for complex cross-functional strategic projects as directed by Senior Project Managers or Program Managers. The Project Manager will support driving and delivering results per charter goals, managing scope, schedule, quality, resources, risk and value/ benefit.  The Project Manager will also manage medium to small projects independently for the business or internal to the function with oversight by more seasoned Program/Project Managers or leadership. A Typical Day Might Look Like this: Plan, manage, execute and deliver a project through its lifecycle within the approved scope, schedule and budget  Secures acceptance and approval of deliverables and perceived value from the Project Lead and Stakeholders  Estimates and coordinates project resources  Maintains the Project Charter, schedule, issues log, budget and risk management plan Manages the risk register and the escalation of risks and issues. Partners with Change...

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...

Regeneron GEO IT is seeking a Senior Architect with advanced expertise in the ServiceNow Security domain, particularly in Vulnerability Response, Integrated Risk Management (IRM), and Security Operations (SecOps). You will be an integral part of the Regeneron GEO IT (Global Enterprise Operations). You will help provide leadership for the entire platform and collaborate closely with IT colleagues with a focus on the Information Security Office.   You will help define business requirements and leverage the ServiceNow platform to configure solutions that align with the platform’s strategic direction.  You will provide expert consultation to all partners with a focus on the Information Security team, provide roadmap consultation and ensure the ServiceNow platform aligns with business strategies and governance decisions.      As a Sr ServiceNow Architect, a typical day may include the following: Design and develop new ServiceNow applications and services with a focus on...

We are looking for a Sr Principal Secure SDLC Software Development Engineer who will be responsible for the design, engineering, deployment, governance and level 3 support of the Regeneron Secure Software Development Life Cycle (SSDLC) framework, solutions, and services, aligning with the Cybersecurity by Design program, in a global environment.   As a Sr Principal Secure SDLC Software Development Engineer, a typical day may include the following: Drive forward the development, enhancement, deployment, communication, and governance of the Regeneron SSDLC roadmap aligned with a comprehensive Cybersecurity by Design strategy.  D evelop and enhance a reliable, scalable, and secure set of SSDLC solutions to efficiently meet business requirements while adhering to the NIST Cyber Security framework.  Drive a continuous improvement approach to securing the Regeneron SDLC program by defining and enforcing security requirements across the full software development...

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...

Regeneron is a leading global biotechnology company that uses the power of science to invent, develop and commercialize life-transforming medicines for patients with serious diseases. The Regeneron Information Technologies team is seeking candidates for the Associate Director, Directory Services Architecture position. This strategic leadership role demands deep technical expertise, vision, and exceptional people management skills. You will be responsible for collaborating on the establishment of the architectural, engineering, deployment, governance, and level 3 support of the Regeneron Directory Services infrastructure, as well as the Directory Services ecosystem and other related services. The Regeneron Directory Services Architect will be responsible for designing solutions for both cloud and on-premises systems. This role includes providing strategic and technical direction and support to internal team members. Key duties involve strategic planning, governance, and making...

In this role you will be responsible for managing our growing employee listening program, keeping a constant pulse on what our people want, feel, and do and providing actionable insights. You will partner with key stakeholders across the enterprise to deliver on regular and ad hoc listening needs, understand how to measure what matters and turn data into meaningful action. The ideal candidate will have a fundamental technical background, strong project management skills, customer orientation and requisite HR experience. Expertise in qualitative research methodology, data management, metrics and reporting, data analytics, data visualization and story-telling are all critical for success in this role.  Strong technology experience with exposure to expanding and/or transitioning listening program vendors is a plus. As the Employee Listening Program Manager, a typical day might include the following: Managing our enterprise workforce lifecycle surveys (e.g., onboarding,...

The Regeneron Genetics Center IT group seeks a Technical Lead for their Application Development team.  You will be responsible for providing technical leadership and oversight of a growing portfolio of solutions that empower our scientists’ research and discovery. This is a hands-on technical position with opportunities to speak to internal clients and manage work end to end. As a Technical Lead, a typical day might include: Developing solutions across the entire stack from web applications to cloud based APIs and services using JavaScript and AWS services. Engaging with internal clients to understand use cases and gather feedback. Managing technical work and timelines. Prioritizing and completing multiple initiatives in an agile environment. Coordinating cloud based (AWS) infrastructure with DevOps team. Keeping informed of new and emerging technologies to incorporate into our technical stack. Ensuring alignment to architecture guidelines and...

The Genome Informatics and Data Engineering team is looking for a passionate Lead Cloud DevOps Engineer with strong technical ability, communication, and collaboration skills. As the Lead Cloud DevOps Engineer, you will be responsible for managing AWS platform, implementation & management of solutions on AWS, from the ground up, to deliver highly scalable services. You will work with stakeholders, rest of the DevOps team, and subject matter experts to build and implement cloud platform solutions. Key focus areas include: Creating & managing containerized applications Building & optimizing CI/CD pipelines and enabling automated deployment of solutions on AWS Cloud with code quality and security testing Support core AWS services – S3, EC2, ECS, EFS, IAM, Lambda, RDS, Redshift, Cloud Formation and develop python & bash scripts for automating routine operations Good to have: Understanding of Data & Analytics. Knowledge on Slurm. Knowledge on WDL....

Preclinical Operations (PCO) is seeking a dynamic Associate Manager, Preclinical Operations  to join the team.  Using program management knowledge and experience in the drug development industry, the successful candidate would provide operational and Project Management support to Preclinical Development (PCD) and Drug Safety & Pharmacometrics (DSP) for multiple assigned projects .  The successful candidate would also provide guidance and input to cross-functional project teams to enable projects to drive to completion. This role has a 3-day onsite minimum requirement in Tarrytown, NY. Relocation can be provided. A typical day as an Associate Manager looks like: Facilitates development and alignment of  integrated PCD/DSP cross-functional project deliverables, plans, timelines and  resources,to align with the overall project plan throughout the project lifecycle from preclinical through commercialization. Ensures effective execution of project plan to...

We are seeking a Sr. Application Developer who can help develop and maintain applications to analyze and interpret millions of genotyped and sequenced human samples, and ensuring we deliver high quality and flexible tools to help scientists perform large scale genome-wide analyses. To enable the Regeneron Genetics Center to generate the knowledge necessary for delivering better medicines to patients, we must empower our scientists to efficiently generate and interact with results derived from millions of sequenced individuals. A proven track record of implementing scalable software tools in a cloud-based computing environment (i.e. AWS, DNAnexus, GCP) is essential for this role. As a Sr. Application Developer, a typical day may include: Implement new features to existing applications to fit users’ needs based on shifting state-of-the-art genetic analysis methods. Modernize and optimize existing applications to improve performance. Develop new applications and...