Administrative Salary in Research Triangle Park, NC

Job DescriptionAbout This Role12-hour rotation, Night shift on a 2-2-3 scheduleThis position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on either a day night, or hybrid shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments.What You'll DoSupervises 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 management.Coordinates manufacturing activities with other departments. This includes providing updates to production schedulers, and working closely with quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance, etc. to ensure execution of PPRs, sampling, validation, etc.Reviews and approves batch related documents, ensuring the proper cGMP documentation practices are followed.Trains manufacturing associates on process activities, including Safety requirements and cGMP requirements. Reviews safety records and identifies/implements corrective measures.Supervises validation activities, ensuring proper and timely execution of validation protocols required in respective areas.Troubleshoots operational and equipment problems and makes recommendations. Also coordinates emergency repairs, changeovers, and preventative maintenance activities with the facilities group.Coordinates and drafts revisions of batch related documents, including batch records and SOPs.Who You AreGrounded understanding of the operating principles for biologics manufacturing. Solid knowledge of the engineering and scientific principles associated with designated areas of responsibility. Understands the primary design principles for the facility (e.g., air pressure differentials, material flow, people flow, utility systems). Basic understanding of the roles of other functional groups within the company. Particularly knowledgeable on safety, GMP, and Human Performance principles. Can influence through effective communication of vision and purpose.QualificationsRequired Skills & Behaviors Leadership (champions the correct behaviors, values driven, sets & maintains culture)Organization (maintaining a supportive work environment, team-development)Accountability (consistency, clear understanding of roles, responsibilities, expectations)Tactical (can allocate resources effectively depending on tasks at hand, according to incoming and outgoing batches/campaignsPreferred Skills Technical/practical cell culture/fermentation experienceCompetency in electronic systems (Oracle, CMMS, Trackwise, etc.)ResourcefulnessRequired SkillsSupervisorBachelor's Degree (STEM strongly preferred) + 5 years of transferrable experience.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bb94bc7-731a-46d7-a165-17ea273fb4b7

Job DescriptionAbout This RoleThis critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be responsible for the strategic and tactical oversight of batch documentation review, continual evaluation during batch production, as well as providing material acceptance decisions for production batches. Through your guidance, your team will ensure compliance to all applicable regulatory requirements and that all GMP activities consistently operate in a state of control so as to successfully undergo domestic and international regulatory agency scrutiny.What You'll DoManage a wide variety of compliance oversight activities expanding several quality subsystems to ensure the safety, efficacy, and purity of the products manufactured by Biogen in the SSM, FVM and Cell Banking areas.Plan, implement, and direct core functions of QA Managers and Supervisors related to site disposition management and all disposition-related activities. Provide assessment of batch acceptance and perform final batch disposition decision for clinical and commercial production batches.Proactively identify and resolve both technical and compliance issues/gaps, Quality system evaluations, and continuous improvement initiatives. Develop and implement aspects of various Quality Systems and system improvements.Analyze and present on departmental and site metrics for compliance. Track and trend key performance indicators and evaluate site performance against these KPIs. Communicate with the Head of Quality in regard to any concerns or risks at the site.Participate effectively in a leadership or membership role for both corporate, global, and site cross-functional teams as a representative of Quality Assurance. Ensure optimum team dynamics and results.Provide mentorship and training within and across site functions.Who You AreYou are an experienced and energetic leader that enjoys leading a Quality Assurance organization through deadline driven initiatives. You are unfazed by the challenges of a complex manufacturing floor and can effectively plan, communicate, and advocate for a "Quality Mindset" throughout all of operations.QualificationsBachelors Degree in a relevant Life Sciences or related discipline + a minimum of 10 years of transferrable experienceAdvanced knowledge of quality systems; particularly lot dispositioning, document lifecycle management, change control and exception managementA strong and successful foundation of experience formally leading Quality Assurance teams in Pharmaceutical or Biotechnology production settingDeep knowledge of FDA/EMEA regulations and complianceExpertise in solving complex problems or diverse scope Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc75f38-40b4-48c6-806c-ee30a0b82449

Job DescriptionThis individual contributor who will report to the Head of Facilities Engineering Technical Authority is accountable for the development and implementation of a comprehensive reliability program that ensures the reliability, availability, and maintainability of our facilities, equipment, and systems across Biogen's global manufacturing network. You will lead functional development, maintenance, continuous improvement, and administration of the global Reliability Engineering program (including End of Life, Single Point of Failure, etc.) including business process ownership, best practices, standards, global program/procedure change management and enforcement. You will work closely with site reliability engineers to champion requirements and benefits; and monitors overall reliability performance at enterprise level in conjunction with individual site reporting from site reliability engineers. You will also develop data-driven technical analysis and/or program recommendations from common reliability engineering KPI's such as mean time between failures, mean time to repair, overall equipment effectiveness, failure rate, availability, maintenance costs, mean time between maintenance, equipment downtime, mean time between loss, cost of unplanned downtime, etc. This is a hybrid role to be based in RTP, NC.Key responsibilities categorized as follows: Program Management / Standards Develop and implement a global reliability program that ensures the reliability, availability, and maintainability of facilities, equipment, and systems across our global network Lead and manage the reliability program across all sites, providing guidance and support to site-level reliability teams. Develop and implement strategies to continuously improve equipment and system reliability, reducing downtime and maintenance costs. Develop and manage the reliability budgets, ensuring that resources are allocated effectively to achieve program goals. Develop and maintain relationships with external vendors and industry experts to stay up-to-date on new technologies and best practices related to reliability. Co-develop data management needed for track and trend program with CMMS BPO and System Admin Data Analysis / Continuous Improvement Develop and implement a data-driven approach to reliability, including the use of analytics, data visualization, and predictive maintenance tools. Monitor and report on program performance, using key performance indicators to track progress towards program goals. Ensure compliance with regulatory requirements, industry standards, and company policies related to reliability. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements. Perform functional equivalency assessment of spare parts. Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Capital Planning Collaborate with cross-functional teams to ensure that reliability is integrated into the design, construction, and operation of new facilities, equipment, and systems. Develop business case for improvements requiring investments and participate in capital planning for reliability related project opportunities. QualificationsRequired:BS in engineering (mechanical, electrical, chemical, industrial) or related facilities engineering discipline At least 6-8 years' experience in Facilities Engineering (or related maintenance, facilities, engineering experience) in Biotech, Pharma or equivalent industry Knowledge of Reliability Engineering / Program Management including asset lifecycle management practices; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning/qualification/validation Knowledge and application of PDMA, FDA and EMEA regulations Ability to influence individuals at both site and enterprise level Strong communication and presentation skills Strong understanding of reliability engineering analytic concepts and methods Established network of technical leaders, peers, and stakeholders in life science industry; actively participates in industry forums, etc. Knowledge of CMMS and engineering & maintenance business practices / procedures Knowledge of laboratory and pharmaceutical process support equipment Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project. Knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics. Good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Preferred:Knowledge of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) Knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable. Membership of relevant professional / technical organizationAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bc960c1-8fbc-4a3f-a65c-e16141c28446

Job DescriptionAs a member of the Global Engineering & Facilities (GEF) leadership team, this individual will lead the Capital Management function. Reporting to the Head of Global Engineering & Facilities, this role will be responsible for creating and maintaining a strategic program for all relevant capital portfolio, capital planning, project management, and project control elements. This role will ensure successful front-end planning, execution, and delivery of the Pharmaceutical Operations & Technology (PO&T) capital portfolio in accordance with safety, quality, scope, cost, and schedule expectations from all relevant stakeholders. This is a hybrid role to be based at our office in RTP, NC.What You'll Do Hold accountability for the global large capital portfolio ($100M - $500M) for Biogen PO&T currently with drug substance and drug product facilities in North Carolina (USA) and SwitzerlandManage the following sub-functions: Capital Portfolio Management, Capital Planning, Project Management, and Project ControlsExecute front end capital planning processes (Long Range Planning, Master Planning, Front End Planning) and strategic capital projects on behalf of site operations. This function will develop, execute, and maintain robust capital planning processes that result in optimized allocation of capital for site operationsSignificantly raise capital project performance level and bring value to site operations through consistent, accurate, and precise delivery of site projects in line with expected outcomes in the most aligned, standardized, efficient, safe, and compliant manner. Be accountable for managing all capital project financial / accounting audits within the scope of the project portfolio managed Manage stakeholders at the senior leadership level and ensure proper sponsorship and execution of roles & responsibilities with interdependent matrix partners #LI-CC1Who You Are You are a key influencer and passionate about project life cycle management. You have mastered the front-end planning process and are ready to shape a team to execute on a global level. You rise to the challenge of building complex business cases and are adept in working with leadership to get the needs of the business met.QualificationsRequired Skills 15+ years combination of portfolio management, project management, project engineering, and project controls embedded in an operational and/or corporate capital projects group responsible for planning of large portfolios (e.g. greater than $100m USD); with at least 10 of those years being in the Pharmaceutical, Biopharma, and/or Medical Devices Industry.BS, MS, or other advanced degree in engineering, construction management or relevant sector Proven project management and technical knowledge with demonstrated ability to deliver safe, effective and fully compliant projects across a broad portfolio Demonstrated leadership abilities leading a capital portfolio and projects organization Experience working directly with executive management on portfolio / project planning and execution Ability to effectively communicate value proposition and business justification for projects and advocate for the needs of the overall project portfolio in order to achieve company goals working with stakeholders across a matrix organization Experience using an enterprise level project and portfolio management tool to execute project control activities Preferred SkillsMBA is preferred but not required PMP and/or PMI certification is preferred but not required Additional InformationOur mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.All your information will be kept confidential according to EEO guidelines.Why Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bd5722b-bf4a-49ae-888a-df731177683f

Job DescriptionPosition Summary:The Senior Case Manager, Patient Services will educate customers about our products, to provide services that facilitate access to our treatments through the removal of non-clinical challenges to ensure safety and compliance with FDA and other regulatory standards. Biogen values team players who are accountable, customer focused, ethical, inclusive, and agile in the ways they work. Our goal is to Care Deeply, Work Fearlessly, and Change Lives. The Senior Case Manager is responsible for acting as a liaison between patients and healthcare providers, as well as other internal and external partners by helping them navigate the complex process to supporting access to prescribed medication. The Senior Case Manager role will require a high level of ownership, problem solving, and empathetic patient focused care from case initiation to case closure. Additionally, this role will utilize strong interpersonal skills for the support and education of patients in their disease state, understanding of medical and pharmacy benefits, Biogen product education and the offering of service option explanations. Primary Responsibilities:* Build trusted relationships with patients and healthcare providers, internal work group partners through proactive communication, timely and accurate execution of deliverables and demonstrated relentless passion for helping patients* Leverage thorough understanding of program services to align support provided based on the unique needs of each patient* Deliver personalized case management to patients and Healthcare Providers including inbound and outbound communication to patients and HCP's regarding solutions to non-clinical challenges to access therapy* Provide personalized reimbursement support to patients, healthcare providers and Biogen field support including benefit investigations, prior authorization information, denial appeals, determining financial qualifications for assistance programs and assisting patients, healthcare providers or other stakeholders through resolution by using critical thinking skills and knowledge of the program services, coverage and industry rules and standards * Conduct necessary benefits, coverage, and payer research/investigations to ensure appropriate resources, compliance with payer appeal policies, practices, and timelines* Adhere to all standard operating procedures and departmental procedures* Ability to travel up to 20%* Meet and exceed performance metrics and quality standards to ensure desired customer experience and business objectives are achieved* Other duties as assignedCompetencies critical to the role: * Strong interpersonal skills; listens well; expresses ideas fluently and logically and is open to input* Professional telephone etiquette; effective verbal and written communication skills * Service oriented; anticipates, recognizes, and meets the needs of others, including patients, providers, field-based team members, peers and other stakeholders.* Pursues goals persistently despite obstacles and setbacks, achieves results* Persuades and influences without authority; fosters an exchange of ideas and support* Detail oriented, accurate and complete; investigational and problem-solving skills * Ability to manage time appropriately and have strong organization skillset * Understanding of Standard Operating Procedures and adaptive, energetic, and comfortable with process improvement and change management* Ability to identify trends in assigned work and proactively communicates to leadership and partnersQualificationsRequired Skills:* A minimum of 3 years of customer service, patient services, case management, or related experience in healthcare environment preferred * Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules) and understands how to access these reimbursement and funding resources* Must have excellent knowledge of the managed care industry, including government payers and procurement* Demonstrated investigational and analytical skills * Ability to utilize strong interpersonal skills that will allow for the support and education of patients, understanding of medical benefits, and communicating support program options that will drive successful outcomes for patients* Work effectively under pressure and prioritize tasks in a fast-paced environment* Ability to work collaboratively in a team structure with a desire to work with and assist peers, prescribers, sales team members, patients, and business partners* Ability to assist peers as needed in order to maintain performance within the team and meet the needs of the customer * Technical proficiency in Microsoft Office Products and CRM or equivalent system* Successful completion of paid training without interruption is a must* Bilingual (English and Spanish) skill is a plus* Requirement to support program operations during holidays and shutdown based on business need* Hybrid Role: candidate has the ability to work from home or in office as required* Candidate has the ability to protect patient privacy in a home, work environment* Candidate must meet/exceed performance metrics to be eligible to work from home* Candidate must have a distraction free environment in order to be eligible to work from homeEducation: High school degree required; Bachelor's Degree preferredAdditional InformationWhy Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9bd977f1-d91e-4f93-98b2-6e128054daed

Job DescriptionAbout This Role The Salesforce Senior Business Analyst role is to fully understand the information and automation needs of the stakeholder community within Patient Services. This understanding is the basis for their essential work which is to elicit, analyze, validate, specify, and document the functional and business needs of stakeholders in the context of delivering IT services and solutions. The role of the business analyst covers several areas and draws upon a variety of analytical skills. From simple understanding of the evolving the day-to-day needs of stakeholders, to creating functional needs breakdowns, to documenting current process flows, (and envisioning future process flows), building business cases, validating detailed designs with users and more; the role of the business analyst is critical to the success of IT in delivering appropriately tailored IT solutions for stakeholders.This is a hybrid role based in RTP, NC.What You'll Do Translate conceptual user requirements into functional requirements in a clear manner that is comprehensible to developers and the project team.Communicate to project managers, sponsors, and other stakeholders throughout the project lifecycle changes and enhancements of business requirements so that issues and solutions are understood.Collaborate with project sponsors to determine project vision and scope.Conduct interviews to gather user requirements via workshops, questionnaires, surveys, site visits, workflow storyboards, use cases, scenarios, and other methods.Work with stakeholders and project team to prioritize collected requirements.QualificationsRequired Skills Minimum of 5 years of Business Analyst experience, preferably in the healthcare or biotech industry.Prior IT work supporting Commercial applications.Salesforce experience required (Health Cloud, Five9, Verint, Twilio, REMS preferred).A bachelor's degree in business administration or a similar field (Management Information Systems, Computer Science, IT)Strong understanding of business processes and functions, with an ability to translate business requirements into technology solutions.Excellent communication and relationship-building skills, with an ability to engage and influence stakeholders at all levels of the organization.Ability to balance short-term needs with long-term goals.Knowledge of emerging technologies and industry trends, with an ability to identify opportunities for innovation and improvement.Proven experience in the following areas:Business AnalysisBusiness Process ImprovementProcess AnalysisRequirements Definition and ManagementUser Experience Design & AnalysisDemand ManagementUser Acceptance Testing (UAT)Agile Methodology using Jira, creating Epics, and writing Jira Stories.Preferred SkillsEnterprise ArchitectureSolution PlanningDesign ThinkingData AnalysisIntegrationsAdditional Information"Diversity is key for the survival of our ecosystem. I believe it is the single most important factor for a balanced flourishing environment where everyone thrives." Guy Hadari - Chief Information Officer-Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9bd977f9-1996-460a-800b-7d3e7e3ced9f