11 donation coordinator jobs found in Durham

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 This position follows a traditional 2-2-3 format from 6a-6P ( Red Day 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...

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 About This Role: As the Head of Global Integrated Digital Execution & Automation Solutions, you will lead and coordinate the digital execution and automation engineering activities across capital projects, lifecycle management, and manufacturing operations. Your role will be pivotal in driving continuous improvement initiatives with a right-first-time mindset, ensuring all activities align with industry standards and Biogen's best practices. Reporting directly to the Head of Global Engineering, you will work closely with global and site functions to support Manufacturing Operations, Quality, and other key stakeholders, building global capabilities in a standardized and reliable manner. Your leadership will guide the development and governance of technical standards, propelling Biogen forward in the digital arena. You will be instrumental in fostering strategic partnerships and ensuring compliance with regulatory and safety guidelines, thereby enhancing Biogen's...

Biogen About this role The Senior HVAC Technician plays a critical role in supporting Biogen site operations by ensuring HVAC and environmental control systems operate safely, efficiently, and in compliance with operational requirements. This position performs both preventive and corrective maintenance across a wide range of mechanical systems that support Facilities, Laboratory, and Manufacturing functions. Work Shift Monday - Friday 8-hour shifts, starting at either 6:30 AM or 7:00 AM ET This role participates in an off-hours on-call rotation to ensure continuous operational support Overtime as required What you'll do Perform preventive maintenance on HVAC and environmental control systems to ensure reliability and compliance Diagnose and complete corrective maintenance work orders supporting Facilities, Laboratory, and Manufacturing operations Operate, maintain, and repair systems including VRF systems, air handling units (AHUs), cold rooms,...

Genesys Genesys empowers organizations of all sizes to improve loyalty and business outcomes by creating the best experiences for their customers and employees. Through Genesys Cloud, the AI-powered Experience Orchestration platform, organizations can accelerate growth by delivering empathetic, personalized experiences at scale to drive customer loyalty, workforce engagement, efficiency and operational improvements. We employ more than 6,000 people across the globe who embrace empathy and cultivate collaboration to succeed. And, while we offer great benefits and perks like larger tech companies, our employees have the independence to make a larger impact on the company and take ownership of their work. Join the team and create the future of customer experience together. VP, Integrated Marketing, Americas Reports to: SVP, Demand Generation Location: United States Role overview The VP, Integrated Marketing - Americas is the regional revenue marketing executive...

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 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 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...