16 jobs found in Durham, NC

Biogen This is an onsite position Monday through Friday business hours, with occasional weekend and off-shiftsupport required About This Role The Biochemistry Manager will lead theBiochemistry function at our biologics drug substance manufacturing facility with a team of direct reports. This role isessential for overseeing release and stability testing, as well as supporting analytical methodtransfer and validation activities. What You'll Do Lead and manage the site Biochemistry team, including hiring, training, andperformance management Provide expert technical guidance and mentorship, supporting investigations, analyticalmethod validation, and process improvements in QC Biochemistry Ensure compliance with Biogen policies, regulatory requirements, and industrystandards, maintaining effective laboratory systems and supporting regulatorysubmissions Serve as the subject matter expert (SME) for Biochemistry during regulatory inspectionsand audits Drive...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

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 This role operates on a 2 2 3 schedule for Day Shift- 6a-6p. 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; including - Upstream (Cell Culture), MAs 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, centrifuges, stainless steel bioreactors up to 15,000L Performing thaws and splits utilizing Aseptic technique What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to...

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 In this Sr. Manufacturing Specialist I 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, changeover protocols, batch production records, solution lot records and deliver on key stakeholder requirements with a minor degree of supervision. Project management and project execution - lead or participate in projects, 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...

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 This position will be hybrid (3 days per week on site) and can either sit at our Cambridge MA location OR our Research Triangle Park, NC location About This Role The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products' distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization. What You'll Do Ensure quality and uninterrupted supply through the application of quality measures throughout the supply...

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...

Biogen About This Role At Biogen, we are driven by our mission to pioneer science for the benefit of humanity - and that includes creating a workplace that protects the health, safety, and well-being of every employee, contractor, and visitor. As the EHS Manager, you will lead the development, implementation, and continuous improvement of Biogen's Environmental, Health, and Safety (EHS) Management System. This role is a key member of the PO&T/EHS organization and is responsible for managing site-specific EHS programs, ensuring regulatory compliance, and promoting a strong culture of safety and sustainability. You will oversee EHS operations, training, communications, and management system processes while partnering closely with business leaders, global colleagues, and functional teams to support Biogen's values of safety, integrity, and accountability. What You'll Do Lead and Manage EHS Programs: Direct site-level implementation of Biogen's EHS Management...