52 jobs found in Durham, NC

Biogen About This Role As a Senior Process Engineer , you will be a key technical authority and Subject Matter Expert (SME) within the Drug Product Engineering Technical Authority . This role is responsible for driving technical excellence across a global manufacturing network, with a specific focus on Oral Solid Dosage (OSD) technologies. We are ideally looking for a strategic engineer with a background in Engineering Consultancy (A+E) who understands the intersection of process design, technologies, equipment and facility architecture. You will ensure the optimal design performance, scalability, and compliance of OSD systems, collaborating with site engineering function to drive modality development, enhancement, and global alignment. This is a hybrid role to be based at our offices in Research Triangle Park, NC. What You'll Do Establish and update engineering standards and best practices for all manufacturing sites, covering both Oral Solid Dosage (OSD)...

Biogen *Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts ( Days 6a to 6p) on a2-2-3 calendarrotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating...

Fidelity Investments Job Description: Principal AI Engineer The Role The Workplace Investing AI Delivery Engineering Team is seeking a Principal AI Engineer with deep expertise in Generative AI, Retrieval-Augmented Generation (RAG), prompt engineering, prompt tuning, and model fine tuning. In this role, you will architect, implement, and scale GenAI solutions leveraging AWS cloud services. You will partner closely with data scientists, other AI & ML engineers, and product teams to build enterprise grade GenAI platforms, including vector search, retrieval pipelines, model orchestration, evaluation frameworks, and responsible AI guardrails. This is a hands on technical leadership role involving engineering strategy, solution architecture, mentoring, and end to end implementation. The Expertise and Skills You Bring Required Technical Expertise * Generative AI - designing, building, and deploying solutions using LLMs, embedding models, and multimodal models. * RAG...

Merck Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The HVAC&R Technician is responsible for providing equipment troubleshooting and maintenance support for ongoing facility facility/manufacturing operation and support growth initiatives at the site. Assists in and develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. The HVAC&R Technician will provide maintenance supporting vaccine process equipment operations. Takes appropriate action to correct Plant...

UNC Health Description Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary: The Medical Assistant II, Certified provides routine clinical and administrative support to providers and other health care team members in an outpatient clinic setting. Works under the clinical supervision of the provider for patient care activities, and under the general direction of the designated manager/supervisor. Responsibilities: 1. Performs rooming and/or intake process, collecting and data, including vital signs, height, weight, and data related to patient's reason for visit. 2. Collects patient and family data, including medical and social history. 3. Reviews patient's current medication list, allergies and preferred pharmacy. 4. Assists the provider as directed, during treatments, examinations and procedures. 5. Collects specimens and performs phlebotomy. 6....

Merck Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The HVAC&R Technician is responsible for providing equipment troubleshooting and maintenance support for ongoing facility facility/manufacturing operation and support growth initiatives at the site. Assists in and develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. The HVAC&R Technician will provide maintenance supporting vaccine process equipment operations. Takes appropriate action to correct Plant...

Biogen **Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts ( Days 6a to 6p) on a2-2-3 calendarrotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). U Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned. What You'll Do Review test data in LIMS Prepare quarterly EM/UM reports Supports testing for all qualification and study directed testing Troubleshoot complex assays Perform microbiology testing...

Biogen About This Role As an Engineer II in Manufacturing, you will be a pivotal member of our dynamic drug substance manufacturing team. Your primary role involves providing engineering technical support and troubleshooting for manufacturing equipment, ensuring smooth and efficient operations. You will actively participate in new product tech transfer activities, contributing to our continuous improvement initiatives. This position allows you to manage small engineering projects under supervision, working closely with contractors and multi-functional teams to enhance existing processes. Your efforts will directly support the design, specification, and installation of new equipment, as well as modifications to existing systems. By executing and tracking validation activities related to manufacturing equipment, you will play a crucial role in maintaining our high standards of quality and compliance. What You'll Do: Provide engineering technical support and...

Biogen About This Role As a Sr. Engineer III in Manufacturing Sciences, you will be an integral member of the global Manufacturing Sciences team. Your primary focus will be on leading, facilitating, and coordinating biologic molecule technology (tech) transfer activities at our Bio Site in RTP. You will create, drive, and communicate technology transfer deliverables while managing the overall tech transfer schedule and metrics. By utilizing technical rigor, analyzing complex issues and identifying business process optimization opportunities, you will provide technical leadership, strategic insights and direction. Your role also involves communicating transfer plans and risk mitigations to senior leadership, ensuring alignment with departmental priorities. This position is pivotal for driving successful tech transfers, supporting both internal programs and those of our strategic partners, and enhancing the value to our business What You'll Do: Coordinate and lead tech...

Fidelity Investments Job Description: Director, Squad Leader / Product Owner - Crypto Wallet & Blockchain, Fidelity Digital Assets Note: Fidelity is not providing immigration sponsorship for this position Fidelity Digital Assets is dedicated to building products and services that help institutions adopt digital assets and innovate within the increasingly digital world of finance. Fidelity Investments began researching blockchain technology and digital assets solutions in 2014, where years of research and development have provided us with the deep expertise necessary to build the future of finance. As a Wallet & Blockchain Squad Leader (Product Owner) on the Fidelity Digital Assets Product Delivery team you would have the opportunity to directly contribute towards this future. The Role We're looking for a team-focused Product Owner with phenomenal interpersonal skills that will work collaboratively across business and technology teams. This role has the...

Fidelity Investments Job Description: The Role The ServiceNow HR Analyst will be a part of a team that will manage day to day enhancements and fixes. This role will facilitate the requirements, design, testing, and delivery of projects and system enhancements while representing stakeholder interests. Your role will also ensure the accurate collection, control, processing, and maintenance of confidential employee record data. This position will have the opportunity to work across many different Fidelity teams. As a ServiceNow HR Analyst, you will manage the end to end implementation of ServiceNow enhancements and defects, research and advise on existing and upcoming capabilities of ServiceNow, research and implement solutions to incidents and requests and update standards and procedures documentation as required. The ServiceNow HR Analyst will also coordinate & Publish HR Knowledgebase articles, assist with the creation of automated test scripts to be used for future...

Fidelity Investments Job Description: Note: Fidelity will not provide immigration sponsorship for this position. Senior Cloud Security Engineer (Azure) The Role As a Cloud Security Engineer, you will work within a diverse team comprised of passionate technologists who believe in the power of innovation and constant collaboration. We believe that small, empowered, self-motivated teams can achieve outstanding things. We are passionate about opensource contribution, sharing our expertise and knowledge with the engineering community while adopting a continuous learning approach supported by a dedicated learning day each week. The Azure Security and Service Enablement squad is seeking a highly technical, hands-on security engineer with experience on large-scale and/or business critical Azure environments. On this squad, you will bring your cloud security skillset to a group of talented engineers that are continuously innovating and improving our capabilities to enable...

Fidelity Investments Job Description: Note: Fidelity will not provide immigration sponsorship for this position In this role on the Privileged Access Management team, your primary responsibility will be to own and operate Fidelity's HashiCorp Vault application. This is an enterprise-class installation providing secrets management services to over 5,000 business unit applications. You will design, develop, and support new and improved access management capabilities that meet Fidelity's stringent cybersecurity policies and requirements. You will administer critical production environments including implementation of monitoring, upgrades, performance & capacity improvements, certifying disaster readiness, improving CI/CD with process automation, and analyzing key metrics and trends. We operate in an Agile framework where you will have an opportunity to participate in sprint planning to provide prioritization, and realistic and achievable estimates. You will also contribute...

Biogen As the Pharmacovigilance Agreement (PVA) Senior Manager, you collaborate with varied levels of cross-functional internal and external global stakeholders in all aspects of timely execution and maintenance of safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) with Corporate Partners. The PVA Senior Manager is integral to the planning, visualization, and archival systems required for on-time development and marketed product SDEAs, PV transfer agreements, and for inspection readiness. This individual contributor role reports to the Head of PV Alliance Management (PVAM) and contributes directly to Biogen's product pipeline and portfolio. What You'll Do Conduct timely outreach for SDEA planning, authoring and stakeholder and corporate partner transparency Manage the SDEA tracker and produce accurate SDEA planning reports and other required status reports Act as an SDEA subject matter expert for audit and inspections and SDEA inbox...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

Fidelity Investments Job Description: Head of Global Sanctions The Role The Head of Global Sanctions is the senior executive responsible for leading Fidelity's global economic sanctions program across all business lines and jurisdictions. This role sets the strategic direction, ensures robust governance and oversight, and drives enterpriselevel sanctions risk management in an increasingly complex global regulatory landscape. You will report to the Global Head of Fidelity's Financial Crimes Compliance program and serve as the firm's sanctions authority, accountable for U.S. OFAC compliance and alignment with global sanctions regimes, including those issued by the UK, EU, Canada, Switzerland, and the UN-where crossjurisdictional divergence and increased regulatory activity require heightened coordination. You will lead the design, execution, and continuous enhancement of Fidelity's sanctions program, supporting strategic priorities, operational resilience, and...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Biogen Facilities Technician II About This Role The FacilitiesTechnicianIIsupports the reliable operation of plant utility systems within a regulated manufacturing environment. This roleis responsible foroperating,maintaining, troubleshooting, and repairing critical utility systems that supportcGMP areas and controlled spaces.This position plays a key role in ensuring safe, compliant, and continuous facility operations. Shift Details: 12-hour shifts Days7:00 AM - 7:00 PM Rotating2-2-3schedule WhatYou'llDo Operate,maintain, troubleshoot, and repair plant utility systems, including: Medium-pressure boilers, chillers, cooling towers, air compressors Reverse Osmosis (RO), USP water systems, water softeners, WFI stills, and clean steam generators Nitrogen and compressed gas delivery systems Electrical systems, including lighting Fire monitoring and sprinkler systems HEPA certifications, biosafety cabinets, and parts...