20 jobs found in Durham, NC

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 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 This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Biogen Shift:2,2,3 night shift (6 PM - 6 AM) About This Role In the dynamic role of Sr. Materials Handler II, you will be an integral part of our manufacturing team, responsible for the efficient handling of raw materials, processing manufacturing orders, and overseeing weighing and dispensing activities. This position focuses on receiving and shipping final drug substances, ensuring a seamless flow of materials that directlysupportsour productionobjectives. Your efforts willmaintaina safe, efficient, and productive environment at every stage, contributing significant value to our operational success.You'llmanage the receipt of GMP items, verify inventory against specifications, and ensure thetimelymovement of materials using our electronic inventory system. As a trusted member of our team, you will play a crucial role in liaising with various departments, ensuring accuracy and consistency in our supply chain processes. WhatYou'llDo Receive all GMP items, verifying...

Biogen This requisition represents multiple open positions in our manufacturing organization. The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities. 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: This role follows a 2-2-3 calendar rotation on nights (6:00 PM - 6:00 AM ET) Internal Shift Details: Black Nights rotating schedule 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; including -...

Biogen This requisition represents multiple open positions in our manufacturing organization. The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities. 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: This role follows a 2-2-3 calendar rotation on nights (6:00 PM - 6:00 AM ET) Internal Shift Details: Red Nights rotating schedule 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; including -...

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 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 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...

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 the Role: This application is for a 6-month student role from July - December 2026. Resume review begins in February 2026. Biogen Manufacturing Engineering at the RTP Pharma site supports two sterile filling lines and an Automated Visual Inspection Machine at the Parenteral Facility and a small-scale filling line, Oligonucleotide Synthesis Manufacturing Area, and an Oral Solid Dose Manufacturing Area in Building 35. Manufacturing Engineering helps with design, installation, modification, troubleshooting and qualification of new and existing equipment. Manufacturing Engineering also provides technical support for Manufacturing and other Engineering Departments. What You'll Do: Detailed description of role including but not limited to: Protocol and report creation for validation of equipment Support continuous improvement projects Example projects may include: Job shadowing during equipment troubleshooting Equipment commissioning and...

Biogen About the Role: This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. As a co-op, you will be embedded within our dynamic manufacturing team at the Pharma Site, focusing on both Oral Solid Dosage (OSD) and Antisense Oligonucleotide (ASO) facilities. Your role will center around supporting critical projects aimed at continuous improvement and lean six sigma methodologies. As we embark on the journey of introducing new capabilities through the start-up of cutting-edge equipment and facilities, your contributions will be pivotal in driving these efforts forward. You will work closely with seasoned professionals within the manufacturing team, gaining invaluable insights into both upstream and downstream processes. Your efforts will not only bolster the efficiency of our operations but also enhance the overall impact of our manufacturing capabilities within the company. What You'll Do: Collaborate daily...

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 The Manufacturing Associate, Lead plays a critical hands-on leadership role within a cGMP manufacturing environment, performing and documenting daily manufacturing operations while ensuring compliance, quality, and efficiency. This role works closely with the Manufacturing Supervisor to coordinate shift activities, allocate resources, and support production, validation, and continuous improvement initiatives. What You'll Do Execute manufacturing processing steps and manufacturing support activities in accordance with batch records, SLRs, control systems, and standard operating procedures. Monitor and control processes, serving as a subject matter expert (SME) for assigned unit operations and process steps. Coordinate and,...

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 the Role: This application is for a 6-month student role from July - December2026. Resume review begins in February2026. TheManufacturing Technical Operations (MTO) team is a critical technical function within manufacturing sites. Its primary mission is to ensure that manufacturing processes, documentation, and systems are robust, compliant, and continuously improved. The group acts as a bridge between Manufacturing, Quality, Engineering, and Manufacturing Sciences, supporting operational readiness and technology implementation.This position would support theLarge ScaleManufacturing Facility in RTP. WhatYou'llDo: The role will offer an opportunity for cross functional collaboration withQuality, Automation, Engineering, and Manufacturing Sciences.Working in MTOwill allow thecandidategainexperiencein a GMP facility at a15,000L Bioreactor scale. They will gain experience in a GMP facility workingto support manufacturing.This is anoffice-basedrole and can...