12 contributing faculty jobs found in Durham

Biogen About This Role This position is on a 12-hour rotation, Night shift on a 2, 2, 3 schedule This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions on our Large Scale Manufacturing Purification Team . The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments. What You'll Do Supervises Manufacturing Associates - observing/instructing, coaching, leading and developing staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives. Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity. Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff 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 About This Role: As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility. Your expertise in GMP activities ensures that our quality systems remain compliant with industry standards. You will lead the charge in managing site inspections, regulatory requests, and overseeing the creation and approval of GMP documents. Your ability to balance departmental workload, mentor team members, and manage key projects will significantly contribute to our team's success. This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment to quality and excellence. What You'll Do: Manage regulatory and partner inspections, ensuring timely inspection setup, support, and closure Lead inspection readiness activities, including planning and execution Process regulatory requests to support submissions and approvals...

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 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 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,...