18 program manager jobs found in Durham, NC

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 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 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 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...

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...

Bug Out Benefits Start Day 1 for Full-Time Colleagues - No Waiting Period! For more information about our benefits, see below! We are proud to be a member of the Rentokil family of companies, the global leader in Pest Control and other services across more than 90 countries. We pride ourselves on being a trusted partner to many of the world's leading brands and serve consumer and business customers across multiple industries. We are extremely proud of our legacy of excellence and constantly work to fulfill our mission to "protect people, enhance lives, and preserve the planet." What do our Pest Control Consultants do? The primary purpose of this role is to sell the company's industry leading pest management services and products to new and existing residential customers, while maintaining a customer-focused service to grow the business. You'll be the face of our national brand to your local community, and your clients will count on you to protect their homes and their...

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...

Apex Systems, Inc. Job#: 3026978 Job Description: We Are Hiring: Teller / Member Service Representative! Role : Teller / Member Service Representative Supporting : Large Financial Services Client Location : Durham, NC (Onsite) Duration: ~5 Months Assignment Type : Contract to Hire Pay Range : $12- $16.00 per /hr. Specific compensation will be determined based on experience, qualifications, and other relevant factors. Position Description: We're seeking a Teller / Member Service Representative to support daytoday branch activities in a highvolume, memberfacing environment. This role is essential in ensuring smooth branch operations, exceptional member service, and accurate handling of financial transactions. You will assist members in person, process teller-line transactions, identify potential fraud concerns, and provide guidance on available products and services. This role requires strong attention to detail, professionalism, and the...

Biogen About This Role: As a Senior IT Business Partner for Biogen's patient engagement initiatives, you will play a crucial role supporting digital patient engagement initiatives within the Patient Services IT team. In this position, you will act as a techno-functional bridge between business stakeholders and technical teams, ensuring seamless collaboration and understanding. You bring deep expertise in patient engagement processes and how technology supports the end-to-end patient journey. You will work closely with franchise leadership, Patient Services, Patient Access, and External Growth & Innovation teams to co-develop and execute a comprehensive digital and technology roadmap. This role is pivotal in shaping the future of patient engagement at Biogen, ensuring that innovative solutions are developed and implemented to enhance patient support and care. What You'll Do: Serve as the patient engagement process expert: Build deep knowledge of how Biogen supports...

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...

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 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 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...

Lincoln Property Company The Building Engineer I is responsible for maintaining, operating, and troubleshooting building systems, including HVAC, plumbing, and electrical systems, focusing on performing routine maintenance tasks, responding to tenant requests, and ensuring systems operate safely under the guidance of senior engineers. Essential Duties and Responsibilities: Perform scheduled maintenance, repairs, and inspections of building systems; address service requests, including hot/cold calls, plumbing issues, and lighting repairs. Troubleshoot minor equipment malfunctions and escalate issues as needed. Replace light fixtures, filters, and other components as required. Maintain accurate records of inspections and equipment performance. Interact with tenants, contractors, and property managers and work closely with senior engineers and technicians to support smooth building operations and resolve tenant issues. Assist with preventive maintenance tasks and...

Biogen This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Sr Associate I has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Sr Associate I has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The Associate identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The QA Sr Associate I performs all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. The Associate should be...

Biogen About This Role In this role,you'llprovide customer-focused technical support in a fast-paced manufacturing environment, helping keep critical production equipment running safely and efficiently.You'llperform corrective and preventive maintenance on complex manufacturing systems while collaborating closely with engineering and manufacturing teams. Your work directly supports reliable operations and helps ensure high-quality products that make a real difference for patients. Shift Details: 12-hour shifts Nights:6:00 PM -6:00 AM Rotating2-2-3schedule WhatYou'llDo Perform corrective and preventative maintenance on filling equipment, isolators, vial washers, autoclaves, parts washers, and automatic vial inspection systems Troubleshoot equipment issues in collaboration with Responsible Engineers and Manufacturing personnel Support day-to-day manufacturing operations, responding to alarms, interruptions, and line issues Complete...

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,...