44 jobs found in Durham

Biogen Job Title: Sr. Analyst I, Material Planning About This Role: As a Sr. Analyst I in Material Planning, you will play a pivotal role in supporting manufacturing planning efforts at our RTP Pharma Manufacturing Site, focusing on both clinical and commercial programs. You will work closely with teams across Manufacturing, Warehouse, Scheduling, Quality, and Procurement to address raw material issues, manage scheduling conflicts, and ensure optimal inventory levels. Your role is integral to driving project success, as you resolve issues and report project status to both your team and management. With a keen eye on analyzing data to help reduce costs and mitigate write-offs. This position requires a balance of independent work and effective collaboration across all business areas and organizational levels. What You'll Do: Manage raw materials planning and inventory control activities, including forecasted demand, stock levels, and expiry reporting. Oversee weekly...

Biogen This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems. Collaborating closely with QC teams, Quality, Planning, Warehouse, Validation, and Manufacturing teams, you will help ensure that operations run smoothly. Your role may also involve assisting with GMP compliance activities, investigation writing, and continuous improvement initiatives. By working independently and...

Biogen This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule About This Role The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities: (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval. WhatYou'llDo Ensures Product documentation and other documents supporting batch execution are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented...

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: This role follows a 2-2-3 calendar rotation on nights (5:45 PM - 6 AM ET) 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 - Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Upstream / Cell Culture: Mammalian cell culture & harvest: Work in Shake flasks, WAVE bags,...

Biogen About This Role: As the Director of Quality Control, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment, testing procedures. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain. What You'll Do: Lead the Pharma Site QC Operations organization - Management of...

Biogen About This Role As a Senior Process Engineer, you will be a key contributor and subject matter expert within the Drug Product Technical Authority supporting Finished Goods (FG) & Oral Solid Dosage (OSD) technologies responsible for driving technical excellence across Biogen's global manufacturing network. This pivotal role ensures the optimal performance, availability, and compliance of equipment and systems supporting device assembly, labelling, packaging, and oral solid dosage drug product operations. These areas cover both large molecule injectables and devices as well as small molecule, which includes blistering and bottling operations. You will collaborate closely with site engineering leads, providing guidance and oversight to engineering teams, and driving modality development, enhancement, and governance. Your expertise will optimize operations and deliver value to the business, maintaining a strong position within Biogen's global framework. This is a...

Biogen This role operates on a 8a-5p, M-F schedule About This Role As a Facilities Technician III, you will operate and repair including medium pressure boilers, HVAC, chillers, cooling towers, air compressors, Reverse Osmosis, WFI stills, Sterility Isolator, parts washers, fire monitoring systems, sprinkler systems, Bio safety cabinets, process waste streams, electrical systems including lighting, nitrogen compressed gas delivery systems. Furthermore, you will provide troubleshooting expertise on problem utility equipment and serve as system expert for the utility systems under guidance of other Technicians when necessary. What You'll Do Operateall utility systems that supply manufacturing. Trainothers as needed on operation and maintenance of utility systems and serveas system expert. Maintain and troubleshoot HVAC systems within the plant Maintainutility systems and respondto critical alarms. Logreadings on various plant equipment systems and investigatewhen...

Biogen About This Role: As the Global Training Compliance - Corporate Quality, you will be at the forefront of ensuring the quality and compliance oversight and execution of our global GxP Training process as member of the Corporate Quality team. This pivotal role involves acting as Quality Unit for the Global GxP Training process and the Business System Owner for the Veeva Vault Training system, ensuring its alignment with both regulatory standards and organizational objectives. You will spearhead the design, implementation, and ongoing improvement of this system, collaborating with cross-functional teams to maintain high compliance standards. By monitoring metrics and KPIs, and escalating issues to senior leadership, when necessary, you ensure that our training process is not only efficient but also enhances our global operations. Your insights will be invaluable during audits and inspections, as you represent the process to regulatory bodies. Embedded within a global...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...

Biogen About this role The (Senior) Medical Science Liaison (MSL) role is a part of US Medical Affairs, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. The (Senior) Medical Science Liaison enables critical stakeholder engagement with Key Medical Experts (KMEs) and other healthcare professionals (HCPs) so they understand the clinical and scientific narrative for Biogen's therapies. Biogen's priority is to continue to foster and enable a diverse and inclusive workforce - representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities - that reflects the communities where we operate and the patients who we serve. What You Will Do Be a credible medical/ scientific expert who engages with KME and HCP to increase confidence in making the best clinical decisions pertaining to disease state and Biogen's products in the near and long term...

Biogen Facilities Technician II The schedule for this role will be a 2 2 3 rotation, 7a-7p About This Role As a Facilities Technician II, your primary duties will be to operate, and repair chill water cooled GMP and non-GMP air handlers. Ability to troubleshoot motor control, perform bearing replacement and alignment, and valve replacement. Knowledge and understanding of steam, HHW and chilled water operational equipment, i.e. steam traps, check valves, control valves. In this role, you will be responsible for the operation, maintenance, and repair of chilled water-cooled air handling units (AHUs), including both GMP and non-GMP systems, as well as associated ventilation and exhaust systems. Key Responsibilities: Operate, maintain, and troubleshoot chilled water-cooled AHUs, exhaust fans, and related HVAC components. Troubleshoot air handler controls connected to Motor Control Centers (MCCs) and Programmable Logic Controllers (PLCs). Diagnose...

Biogen About This Role We are seeking a motivated and technically driven Automation Engineer to join our growing Automation Systems Engineering team. In this role, you will support the administration, reliability, and continuous improvement of multiple GMP-critical automation platforms that enable large-scale biologics production. This position offers hands-on experience across a wide range of automation technologies-including DeltaV, TruBio, OSIsoft PI, InfoBatch, FactoryTalk, TiPS, TopView, and Syncade-while engaging cross-functionally with Manufacturing, Quality, Facilities/Utilities, and IT. What You'll Do Automation System Administration & Support Provide daily administration, monitoring, and troubleshooting for the site's Batch Control System (Emerson DeltaV). Support Single-Use Bioreactor operations by administering and maintaining TruBio control platforms. Maintain and configure the Manufacturing Data Historian and contextualization layers...

Biogen Facilities Technician II (Night Shift) The schedule for this role will be a 2 2 3 rotation, 7p-7a on Night shift About This Role As a Facilities Technician II, your primary duties will be to operate, and repair chill water cooled GMP and non-GMP air handlers. Ability to troubleshoot motor control, perform bearing replacement and alignment, and valve replacement. Knowledge and understanding of steam, HHW and chilled water operational equipment, i.e. steam traps, check valves, control valves. In this role, you will be responsible for the operation, maintenance, and repair of chilled water-cooled air handling units (AHUs), including both GMP and non-GMP systems, as well as associated ventilation and exhaust systems. Key Responsibilities: Operate, maintain, and troubleshoot chilled water-cooled AHUs, exhaust fans, and related HVAC components. Troubleshoot air handler controls connected to Motor Control Centers (MCCs) and Programmable Logic...

Biogen Shift Information This position will work a 2,2,3 schedule working 12-hour NIGHT SHIFT from 6 PM to 6:00 AM. About the Job Provide customer-oriented service and support in a fast-paced manufacturing environment. Performs corrective and preventative maintenance on manufacturing Filling equipment, Isolators, Vial Washers, Autoclaves, Parts Washers, and Automatic Vial Inspection equipment. This position requires a solid understanding of manufacturing systems including mechanical, electrical and control principles. What You'll Do Collaborate with Responsible Engineers and Manufacturing personnel to troubleshoot equipment problems. Complete all assigned corrective work orders and Preventative Maintenance work with attention to detail and maintaining required GMP documentation. Follow Standard Operating Procedures in performance of assigned duties. Maintain appropriate maintenance and repair logbooks. Support rotating on-call support of manufacturing...

Biogen Job Title: Sr. Technician II, Instrumentation & Controls Schedule is Mon-Friday, 7a-330p About This Role: As a Sr. Technician II in Instrumentation & Controls, you will play a crucial role within the PO&T team by performing both corrective and preventative calibrations on a variety of manufacturing, facility, and laboratory analytical instruments. Your expertise will support manufacturing and laboratory personnel in maintaining the functionality and accuracy of critical equipment, ensuring seamless operations. You will often collaborate with engineering and validation teams to address equipment failures and support validation activities. By authoring changes to procedures and job plans, you will help refine our processes and maintain our high standards. This role is vital in minimizing downtime, enhancing productivity, and ensuring compliance with industry regulations, thereby supporting the overall business objectives. What You'll Do: Perform...

Biogen About This Role The Sr Associate I will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, Actions, and environmental excursions. The Sr Associate I must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion May provide Quality Unit...

Biogen This is an onsite position, Monday through Friday, with occasional weekend and off-shift support required About This Role We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies. What You'll Do Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel practices Develop, implement, and maintain contamination control strategies aligned with internal quality standards and global regulatory expectations (e.g., EU Annex 1, FDA...

Biogen About This Role: As a Senior Category Manager for Direct Materials, you will play a pivotal role in optimizing and innovating key categories crucial to Biogen's operational footprint. Reporting to the Associate Director of Global Strategic Sourcing, this position sits on the Global Strategic Sourcing team, focusing on the direct material space for internal manufacturing operations, including categories like chemicals, filters, and resins. You will be responsible for managing category strategies and sourcing initiatives across various modalities, such as Biologics, Oral Solid Dosage, Parenteral filling, ASOs, and Clinical Label & Packaging. This Senior Manager will ensure the needs of the business are met by leading category management, sourcing strategies, and sourcing process from defining business needs, knowledge of supply marketplace, executing RFx events, lead contract negotiations, supply risk management, and supplier relationship management. What You'll...

Biogen This position follows a traditional 2-2-3 format from 6p-6a (Night Shift) About This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. In coordination with Supervisor, schedules tasks for a given shift and plan...