32 team leader i jobs found in Durham

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 *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 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...

Biogen This application is for a 6-month student role from July - December 2026. Resume review begins in January 202. Cell Culture Development works to create high quality, robust processes that are manufacturing-ready. We use carefully designed experiments to target areas for improvement identified from previous biological process knowledge/experience. We balance understanding/fundamental science with efficiency to make risk-based decisions that ensure safety/success of any process. Members of this team have the opportunity to contribute directly to current challenges in the group. While performing diverse, hands-on experiments, an individual will learn about a wide variety of research areas, including bioprocess development, process analytical technology, and control strategy. What You'll Do: This co-op is onsite and lab-based. Perform and document a variety of functions in support of the development of new technologies for cell culture manufacturing processes of...

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 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 About This Role We are seeking a new team member to support the Utility Operations Dept. in a GMP and Non-GMP environment. In this role you will be responsible for operating the Plant Utility systems both GMP and Non-GMP, starting and stopping various utility systems using a BMS and DeltaV control system, monitoring utility systems, responding to all alarms, and performing rounds which include taking daily log readings on various utility systems. Individuals in this team will become trained and skilled in all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision. What You'll Do Operate plant utilities under guidance of a qualified operator. These systems include: medium pressure boilers, chillers, glycol system, cooling towers, air compressors, waste neutralization and compressed air, fire suppression systems Operate the following GMP systems under guidance of a qualified operator: USP...

Biogen Position schedule: 2nd shift The schedule for this position can be either Tues-Fri 2PM to midnight OR Mon-Fri 2PM to 10PM (dependent on applicant preference). There is a rotational on-call schedule for weekends for this position. *MUST be available to work day shift while training for approximately 6 months About This Role The Sr Tech II performs corrective and preventative calibrations on manufacturing and laboratory analytical instrumentation with limited supervision. Supports manufacturing and laboratory personnel in the use, maintenance and repair of on-site instrumentation and test equipment. Supports Validation and engineering activities when called upon. Authors changes to procedures and job plans when required. What You'll Do Performs scheduled calibrations Performs unscheduled corrective calibrations and repairs Installs new instrumentation. Provides engineering and validation support Authors changes to procedures, job plans, and LOTO...

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 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 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...