16 research development intern jobs found in Durham

Biogen About This Role Biogen studies highly complex, devastating, and burdensome diseases and there are still significant challenges in how we understand and treat them. In the Quantitative Sciences Development Organization we aspire to transform patients' lives by accelerating disease research using best in breed and emerging techniques. Leveraging applied machine learning and emerging technologies, we drive solutions to advance research, clinical care, and patient empowerment. We stand with our colleagues across Biogen developing pioneering treatments. We believe that now, more than ever, biology and technology should go hand-in-hand to better meet patient needs, while enabling a shift towards more prevention-focused, affordable, and equitable care. What You'll Do As a Machine Learning Engineer, Operations and Health Systems Research, you will: Design, develop, and implement complex end-to-end data pipelines, engineer features and disease models to...

Biogen About This Role: As the Head of Global Integrated Digital Execution & Automation Solutions, you will lead and coordinate the digital execution and automation engineering activities across capital projects, lifecycle management, and manufacturing operations. Your role will be pivotal in driving continuous improvement initiatives with a right-first-time mindset, ensuring all activities align with industry standards and Biogen's best practices. Reporting directly to the Head of Global Engineering, you will work closely with global and site functions to support Manufacturing Operations, Quality, and other key stakeholders, building global capabilities in a standardized and reliable manner. Your leadership will guide the development and governance of technical standards, propelling Biogen forward in the digital arena. You will be instrumental in fostering strategic partnerships and ensuring compliance with regulatory and safety guidelines, thereby enhancing Biogen's...

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

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 About This Role The Engineer II, Facilities role focuses primarily on temperature-controlled chambers and supports validation activities across the manufacturing facility. You'll work closely with Facilities, Utilities, Manufacturing, Quality, and Engineering teams to ensure GMP assets are properly commissioned, qualified, and maintained. What You'll Do Support validation and qualification activities for temperature-controlled chambers and related GMP equipment Assist with the development and execution of IQ/OQ/PQ protocols under guidance from senior engineers Participate in commissioning and qualification of new and existing equipment Support Facilities operations by helping troubleshoot equipment issues and identifying improvement opportunities Assist with change controls, deviations, and CAPAs in a GMP-regulated environment Collaborate with cross-functional teams including Facilities, Utilities, Manufacturing, Quality, and Maintenance Lead...

Biogen This is a full time on-site position with M-F business hours About This Role The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a mannerconsistent with site and Corporate policies, cGMP, safety, environmental and humanresources policies and procedures. This individual will assist with regulatory and third party audits, aid in the development and implementation of GlobalQualitySystems, and manage Quality projects and other...

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...

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 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...

Biogen About This Role As a Principal Application Specialist, you will play a critical role in designing, building, implementing, and maintaining Veeva Vault Document Management System. Biogen is undergoing a business transformation with technology as a core enabler. Veeva Vault QualityDocs is a critical component of this transformation, and you will be the ultimate driver, leveraging your expertise to ensure high-quality service delivery, optimal system performance, and seamless user experiences. Acting as the IT System Owner for Veeva Vault QualityDocs, you will collaborate closely with cross-functional teams, including business analysts, technical architects, system configurators and project managers, to deliver upgrades, enhancements, new modules, and other initiatives aligned with strategic business roadmaps. Your work will directly support Biogen's Employee Experience and GxP compliance, ensuring that our document management system meets regulatory requirements and user...

Biogen About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You'll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products. Primary duties include: Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority...

Biogen About This Role As a Principal Risk Based Quality Management Data Monitor, you will play a critical role in shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards. You will be at the forefront of implementing Risk-Based Quality Management (RBQM) strategies-ensuring patient safety, regulatory compliance, and data integrity across all phases of clinical research. You'll collaborate closely with biostatistics, data science, safety/pharmacovigilance, clinical operations, and vendors to detect and triage signals early, optimize KRIs/QTLs, and drive continuous process and technology improvements across the portfolio. This position is ideal for someone who thrives on analytical thinking, cross-functional collaboration, and using RBQM and advanced analytics to keep clinical trials running smoothly and safely. What You'll Do Partner with cross functional teams to identify critical data and processes (CDPs) and associated...

Biogen About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: 12-hour shifts Nights: 6:00 PM - 6:00 AM Rotating 2-2-3 schedule Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Product (Parenteral Filling) facility in Research Triangle Park (RTP). These teams are the backbone of our operations-each playing a critical role in delivering life-changing therapies to the patients who need them. Our teams are organized by key steps in the biomanufacturing process. Parenteral Filling Manufacturing Associates execute critical aseptic operations in a controlled cleanroom environment governed by Current Good Manufacturing Practices (cGMP). What You'll Do Parenteral Filling Operations Include Aseptic filling of drug product into vials, syringes, or cartridges Operation of automated and semi-automated...

Biogen About This Role The Global Engineering and Facilities team is looking for an experienced Senior Facilities Engineer with a Civil, Structural and Architectural focus to support Manufacturing, Utilities and Facilities based projects, execute feasibility studies and participate on site committees, engineering teams, and other industry forums. This individual contributor role within the Biogen Facilities Engineering Technical Authority function is accountable for subject matter expertise in the CSA discipline. Experience with (GMP) design in pharmaceutical and biological applications including clean room systems and contamination control will be key in ensuring appropriate design principles for capital projects. This Engineer should also demonstrate competency in other facilities disciplines including Plant Utilities, Clean Utilities, HVAC, and Electrical / Instrumentation & Controls. At Biogen, Subject Matter Expertise is demonstrated by possessing a comprehensive...