Jobs at Biogen
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Head of Device Development
Company: Biogen
Location: Cambridge
Posted Mar 09, 2024
<p><b>Job Description<b> <p><p>The head of the device development group is responsible for the development of stateoftheart drug delivery systems that have the potential to transform the way medications are delivered to patients You will lead a team of highly skilled engineers and scientists in the endtoend development commercialization and life cycle management of devices used across the multiple disease indications and modalities of Biogens clinical and commercial portfolio The product scope includes Class 13 medical devices for multiple routes of drug administration The therapeutic modalities include but are not limited to small molecule oligonucleotide and biologics The responsibilities also include optimizing the infrastructure design control processes and technical capabilities needed to lead the industry in drugdevice combination product therapies that are usercentric innovative reliable and environmentally sustainable The development of combination products and medical devices is a highly crossfunctional exercise that requires coordination and input from multiple functions across Biogen and external partnerships <p> <p>In addition to leading the device development function the head of the device development group will lead the technical evaluation of novel device technologies setting the strategy for the Device Pillar within Biogen The Head of Device Development engages with a crossfunctional team of experts from regulatory sciences preclinical safety clinical development clinical operations medical affairs and clin pharm This team is accountable for the successful integration of the platform device in the relevant clinical assets plans Importantly the head of device development will coach mentor and develop team members to ensure goals are accomplished organization objectives are met and team members are empowered and successful<p> <p><strong>What Youll Do <strong><p> <ul><li>Lead in the development of new and innovative device technologies processes solutions and products<li> <li>Provide leadership develop strategic direction for the department to ensure business and technical objectives are met<li> <li>Direct people management responsibility internally and external resources to develop test and manufacture devicescombination products<li> <li>Coach and mentor team members on successful integration of device development combination product verification and validation testing in clinical development and commercial launch plans<li> <li>Search and evaluate external landscape for drug delivery device technologies to recommend device strategies for clinical and commercial assets<li> <li>Lead crossfunctional teams of senior leaders to align strategies related to device development and advance innovation such as implantable devices across all modalities for clinical and commercial assets<li> <li>Liaise with external partners to ensure ontime and high quality execution of development and manufacturing activities for clinical and commercial assets and commercial supplies continuity<li> <li>Develop support strategy for programs or platforms with key business partners in support of the analysis of highly complex issues in a technical area and establishes resolutionsdecision points in a given programproject<li> <li>Advise management and key stakeholders and provide key input in broad ranging strategic projects including operational excellence and business development opportunities eg combination product roadmap continuous improvement device selection external partners opportunities <li> <li>Inform regulatory strategies author and or approve regulatory filings and briefing documents and represent Biogen in facetoface meetings with regulatory agencies as needed<li> <li>Establish plans for talent development diversification and professional development for employees<li> <li>Functions as engineering SME in single or multiple engineering topics<li> <li>Supports the development and validation of departmental project and program budgets and goals<li> <li>Identifies novel and nascent technically innovative opportunities developing IP as appropriate<li> <li>Establish external partnerships and collaborations with vendors and SMEs to advance specific projects<li> <li>Applies a high degree of business acumen and technical judgment to product and process improvement<li> <li>Communicates overall strategy of the projects and initiatives to other stakeholder both internally and externally<li> <ul><p><strong>Who You Are <strong><p> <p>You are an experienced leader with the ability to lead teams through uncertainty in a dynamic environment You should have a deep understanding of all aspects of medical device development and manufacturing processes for assembly of medical devices You also have a strong knowledge of implantable devices and new commercial devices introduction regulatory and compliance requirements of device design controls and drug device combination products You have the ability to connect with all levels of the organization to influence while embracing and driving change You have a passion for driving technical excellence in everything from product conceptualization throughout product development cycle to regulatory submissions that ultimately deliver life changing therapies to patients<p> <p><b>Qualifications<b> <p><ul><li>Masters degree in engineering with at least 15 years of relevant experience Equivalent experience equals a bachelors degree and 20+ years of relevant experience PhD and comparable experience may also be considered<li> <li>Experience in drugdevice combination products and related regulations in the medical device or pharmaceutical industry<li> <li>Deep knowledge of ISO13485 and Quality System Requirements applicable Industry and Regulatory Standards and Guidance Documents<li> <li>Applies a high degree of business acumen and technical judgment to solve problems<li> <li>Demonstrated track record of successful end to end device development<li> <li>Strong project management skills<li> <li>Exceptional people leadership track record in a matrixed environment including mentoring coaching amp motivating engineers<li> <li>Strong stakeholder management and negotiation skills when working with internal and external partners<li> <li>Excellent verbal and written communications skills with technical or multifunctional audiences<li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
PO&T Administrative Coordinator
Company: Biogen
Location: Cambridge
Posted Mar 09, 2024
<p><b>Job Description<b> <p><p><u><strong>About This Role<strong><u><p> <p>The Pharmaceutical Operations amp Technology POampT group is looking to hire an Administrative Coordinator role The POampT Administrative Coordinator is responsible for managing the activities and priorities calendar to ensure that POampT is prepared to meet expectations prepare deliverables and that full awareness and coordination takes place to ensure organizational success This includes both immediate and midterm plans including Leadership team meetings All Staff Meetings Management Committee meetings EC meetings BOD meetings etc<p> <p>The incumbent prepares schedules flags conflicts and ensures the Strategic Operations leader the Exec Admin supporting POampT and the POampT EVP has ready access to deadlines is aware of personally owned deliverables and has enough time to effectively prepare and has general line of sight to forward looking events<p> <p>In addition to above this position is part of a team responsible for communicating critical business information to key internal and external stakeholders at the highest organizational levels This position will support those efforts as needed to include putting together presentation materials or supporting their production as needed gathering information tracking key metrics and supports other communications and engagement activities<p> <p>This role is an individual contributor role with broad impact across the global POampT organization<p> <p><em>This is a hybrid role to be based at our Headquarters in Cambridge MA <em><p> <p><u><strong>What Youll Do<strong><u><p> <ul><li>Create and manages the POampT organization and EVP of POampT calendars and schedules to ensure key stakeholder meetings priority deliverables external and internal commitments and employee engagement activities are organized and scheduled to logically flow in terms of timing and that sufficient awareness of timing is in place so that the content is created thoughtfully and relevant dependencies can be managed Conflicts dependencies and immediate and midterm deliverables are flagged<li> <li>Organize POampT EVP touchpoints both internally and externally needed to meet deliverables timing of meetings Ensure EVP and Head of Strategic Operations have line of sight to short term and midterm deliverables and support their efforts to meet those deliverables which may include scheduling meetings or information gathering as needed<li> <li>Provide administrative operational and coordinating support as part of the Strategic Operations team to ensure POampT is set up for success This includes support for information gathering metrics tracking presentation preparations calendaring scheduling and meeting organizing Partners directly with members of the Strategic Operations team the POampT EVP the POampT SLT and their teams internal and external stakeholders etc<li> <li>Maintain currency and accuracy of POampT organization and EVP of POampT schedule recognizing that the realization of overall POampT strategic goals including initiative execution and capability integration are dependent on successful organization and that the coordinatingscheduling role plays an important part<li> <ul><p><b>Qualifications<b> <p><p><u><strong>Who You Are<strong><u><p> <p>You should have knowledge in the biotechnology and pharmaceutical industries especially in operational aspects You should also have demonstrated experience working in a highly matrixed organization You should also have high interpersonal and collaborative skills and should have the ability to work with senior leaders comfortably You should also understand Biogens culture organizational structure and processes The incumbent should have exceptional capability in understanding the importance and impact of executive level meetingsactivities and translating meetings to a functioning schedule that enables the organization to best prepare and deliver <p> <p><u><strong>Requirements<strong><u><p> <ul><li>Minimum of 5+ years of relevant experience<li> <li>Must have demonstrated experience working in a highly matrixed fast growing and global biopharmaceutical organization<li> <li>Strong ability to assimilate information and make prioritization recommendations to best utilize EVP and organizational time<li> <li>Excellent interpersonal skills highly collaborative<li> <li>Understands Biogen culture organizational structure and processes<li> <li>Strong organizational skills project timeline management capabilities<li> <li>Demonstrated business acumen with the ability to draw insights from information and translate that information to understand impact to schedules and priorities<li> <li>Strong computer expertise in Microsoft products including expertise in Powerpoint and Excel<li> <li>Bachelors degree in Life Sciences Chemistry Pharmacy Engineering Organizational Effectiveness Communications or related field preferred <li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Sr. National Account Manager, Trade Accounts
Company: Biogen
Location: Cambridge
Posted Mar 10, 2024
The Sr. National Account Manager, Trade Relations is a crucial role responsible for managing wholesalers, specialty distributors, and GPOs for BBU's product portfolio. The position requires strong professionalism, integrity, and relationship-building skills. Key responsibilities include developing strategic account plans, negotiating and managing DSAs, and conducting quarterly business review meetings. The ideal candidate should have 7-10 years of pharmaceutical trade management experience, GPO experience, and strong analytical skills. Biogen offers a unique focus on neurological and rare diseases, a culture of inclusion, and opportunities for professional growth.
Strategy & Operations Lead, Specialty Franchise
Company: Biogen
Location: Cambridge
Posted Mar 13, 2024
<p><b>Job Description<b> <p><p>You will be the righthand person for the Head of Specialty Franchise supporting the operations of the Specialty Leadership Team and helping set the overall strategy for how the Specialty team needs to evolve in response to a rapidly changing payer and policy environment Shehe will develop deep expertise in one of the most important and most rapidly evolving parts of the pharmaceutical industry with a unique vantage point on how key decisions are made The role is an empowered member of the Specialty LT and will ensure operational excellence by establishing and maintaining a portfolio of key initiatives in close collaboration with the Specialty LT and crossfunctional leaders This is a high impact role that will provide significant learning and development opportunities for the right individual and can act as a steppingstone to a range of leadership roles for a high performing candidate <p> <p><strong>What Youll Do <strong><br > Be a trusted strategic partner to Head of Specialty including proactively highlighting business critical risksopportunities and planning and directing the most critical organizational financial and operational activities<br > Identify opportunities to establish and continuously improve business practices and processes to maximize resources and achieve operational excellence across the Specialty Franchise <br > Drive specific strategic projects on an adhoc basis as directed by Head of Specialty Franchise <br > Facilitate alignment between Franchise team and cross functional partners <br > Assist with regular and adhoc executive communication and reporting to US President North American Leadership Team and Executive Committee <br > Act as a delegate for Head of Specialty Franchise when needed <p> <p><strong>Who You Are You <strong><br >have strong leadership skills knowledge of biopharma industry standards and practices and experience in program management and business process While you hold accountability above all else you must also possess the ability to generate enthusiasm the ability to quickly gain trust and respect of peers and senior leadership and have a track record of successfully driving results through strong partnership with others <p> <p><b>Qualifications<b> <p><p><strong>Required Skills<strong><br > Bachelors degree required MBA or other advanced degree preferred <br > 10+ years of experience consulting andor leading complex programs and initiatives <br > Ability to lead and influence in the matrix and cultivate strong internalexternal network <br > Excellent analytical strategic thinking creativity and problemsolving skills Selfstarter comfortable navigating through ambiguity <br > Great interpersonal skills and ability to lead through influence in a matrixed environment <br > Experience structuring and managing to timelines and project flows <br > Demonstrated trackrecord of excellence and rapid growth with an ability to balance multiple priorities <br >Preferred Skills <br > Familiarity with US Pharma commercial landscape and US payer dynamics <br > Strategy consulting skillset<p> <p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Head of Site Supply Chain, RTP Pharma
Company: Biogen
Location: Raleigh-Durham, NC
Posted Mar 13, 2024
<p><b>Job Description<b> <p><p><strong>About This Role<strong><p> <p>The Head of Site Supply Chain is a key member of the RTP Pharma site leadership team and is accountable for all Materials Management functions warehouse and site logistics operations site planning and scheduling and related drug substance and drug product manufacturing support including technical transfers equipment modifications validation changeovers and routinenonroutine facilities maintenance projects pertaining to materials This role will also be responsible to lead site SampOP<p> <p><strong>What Youll Do<strong><p> <ul><li>Direct warehouse activities including inventory control shipping receiving intersite transfers GMP storage and cycle counting<li> <li>Oversees the site Materials planners to ensure that safety stock strategies are in place and adhered to and that manufacturing Bill of Materials are in ERP to support proper procurement of raw materials needed for drug substance and drug product manufacturing campaigns In addition ensure allocation of API andor drug substance is secured in time to meet production schedules<li> <li>If applicable direct dispensary operations for manufacturing operations in support of manufacturing shift structures Responsible for all safety quality training and compliance regulations associated with the dispensing staff<li> <li>Direct site scheduling and issuance teams which includes the responsibility for providing the integrated manufacturing finite schedule for all the manufacturing factories<li> <li>Direct site planning analysts in the development of the site master plan site production risks and mitigation strategies and lead and coordinate and facilitate site SampOP<li> <li>Ensure accuracy of ERP and MES systems related to all actions associated with materials management<li> <ul><p>This position reports directly to the General Manager of Manufacturing Operations and collaborates closely with global materials resource planning site Quality Control site Quality Assurance and Finance The position will direct the development of departmental workflows workload management guidance instructions or procedures and general technical support to crossfunctional manufacturing lab operations and office staff and is as such critical to ongoing operations<p> <p><strong>Who You Are<strong><p> <p>You are an experienced Supply Chain leader with both experience in and a passion for managing multifunctional teams in a highly regulated environment<p> <p><b>Qualifications<b> <p><p><strong>Required<strong><p> <ul><li>Bachelors Degree BABS from a fouryear college or university in Engineering Business Finance or other related field <em>MS andor MBA strongly preferred<em><li> <li>Minimum of 10 years of related experience and training andor an equivalent combination of education and experience<li> <li>Minimum of 5 years of people management experience<li> <li>Working knowledge of materials and supply chain management<li> <li>Strong knowledge in inventory management systems Working knowledge of ERP systems is essential<li> <li>Excellent project management skills<li> <li>Ability to travel on occasion to other Biogen sites for collaboration support and training<li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Investigator II
Company: Biogen
Location: Raleigh-Durham, NC
Posted Mar 12, 2024
<p><b>Job Description<b> <p><p><em>This sitebased role supports Manufacturing Operations primarily during core weekday business hours but may require offhours support<em><p> <p>The Investigator II is responsible for maximizing organizational learning and improvement from Quality deviations This team applies systematic and analytical cause analysis techniques in direct support of manufacturing operations The Investigator II applies appropriate methodology for each given situation facilitates investigation team meetings conducts interviews collects data and synthesizes data to identify causes and casual factors The Investigator II will support major amp critical deviations collaborating with the Learning Teams to support corrective actions<p> <p><strong>What Youll Do<strong><p> <ul><li>Leads investigations for Quality deviations and incidents as required Conducts Quality investigations with focus on performance improvement and risk reduction in alignment with Quality Management System requirements<li> <li>Identifies root and contributing causes and makes recommendations to correct andor prevent recurrence <li> <li>Document investigation reports and findings in designated Quality systems<li> <li>Ensures required management and Quality approvals on final investigations while satisfying established due dates<li> <li>Facilitate corrective and preventive action agreement with stakeholders<li> <li>Facilitates internal sharing of investigational findings and risk knowledge<li> <li>Contributes to metrics related to investigation process and CAPA effectiveness<li> <li>Present investigations during internal and external audits<li> <li>Collaborates crossfunctionally to ensure robust investigation conclusions effective communication and sharing of learnings<li> <ul><p><strong>Who You Are<strong><p> <p>You thrive in an environment that is not prescheduled or mundane You constantly seek to understand and to learn more with minimal guidance You are comfortable handling and refocusing people from various functions and with various perspectives You encourage handling the right problem to help the organization improve as a whole no matter how challenging that fix may be<p> <p><b>Qualifications<b> <p><ul><li>MS degree STEM preferred plus a minimum of 12 years of transferrable experience <em>OR<em><li> <li>BS degree STEM preferred plus a minimum of 3 years of transferrable experience <em>OR<em><li> <li>Experience driving complex andor high impact investigations in an industrialplant environment<li> <li>Experience supporting Biopharmaceutical Manufacturing operations<li> <li>Experience in management of diverse stakeholders with strong interpersonalinfluencing skills Ability to communicate effectively across organizations Ability to balance resource demands from multiple internal customers<li> <li>Experience in Technical writing<li> <ul><p><strong>Additional Requirements<strong><p> <ul><li>Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent clear and concise narrative<li> <li>Ability to interpret technical information and documentation used for operations and production activities<li> <li>Demonstrated experience in systematic cause analysis methods including Event amp Causal Factor charting Logic Fault Tree and similar techniques<li> <li>Effective facilitation skills<li> <li>Experience in management of diverse stakeholders with strong interpersonalinfluencing skills Ability to communicate effectively across organizations Ability to balance resource demands from multiple internal customers<li> <li>Practical knowledge and application of cGMP cGLP EMEA and OSHA compliance regulations and inspections plus experience interfacing with inspectors investigators andor agency personnel<li> <li>Experience interpreting technical information and documentation used for operations and production activities<li> <li>Experience balancing resource demands from multiple stakeholder groups including Manufacturing Quality and Engineering<li> <li>Experience in performance improvement with basis in Human and Organizational Performance principles<li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Senior Capital Project Manager
Company: Biogen
Location: Raleigh-Durham, NC
Posted Mar 13, 2024
<p><b>Job Description<b> <p><p><strong>About This Role<strong><p> <p>Join our dynamic team as a Senior Capital Project Manager III and be a key player in our mission to deliver excellence in capital project management Reporting directly to the Head of Capital Project Management youll become an integral part of our missiondriven organization The Capital Project Management function is at the heart of our success responsible for orchestrating the seamless delivery of capital projects each exceeding $1M in value on behalf of site operations We operate under a robust systematic stage gate delivery approach aligned with global best practices and standards ensuring that every project we undertake is a resounding success<p> <p>Your mission as a Senior Capital Project Manager III is to significantly elevate capital project performance and bring substantial value to site operations You will consistently accurately and precisely deliver site projects in line with expected outcomes as defined in the approved business case This role encompasses every aspect of project management from the precapital feasibility stage through project closeout You will also play a pivotal role in ensuring the successful outcomes of financialaccounting audits for the projects you manage<p> <p><strong>What Youll Do<strong><p> <ul><li>Feasibility Collaborate under the guidance and leadership of the Capital Planning Manager to support the development of frontend planning deliverables for individually assigned project opportunities Activities encompass the development of a business case scope cost estimates budgets schedules and project risk assessments<li> <li>Projects Oversee all aspects of an individuallyassigned portfolio of capital projects of various sizes including budgets schedules engineering construction coordination and safety Collaborate closely with project sponsors and other stakeholders to align on project requirements goals and objectives Lead crossfunctional teams to achieve project success concerning functionality budget safety quality and schedule This includes onboarding and oversight of external contractors engineering firms construction managers staff augmentation etc contributing to project execution Be accountable for ensuring successful outcomes of financialaccounting audits for managed projects<li> <li>Assist with the development and implementation of internal policies and procedures as required for the continuous improvement of functional group operations including training contract development and capital project execution procedures Ensure that best practices and procedures are updated and adhered to during capital project execution<li> <ul><p><strong>Who You Are<strong><p> <p>You possess engineering and project management experience in the construction of new facilities and retrofits of operating biotechpharmaceutical manufacturing facilities with direct involvement in engineering construction commissioning or validation of capital projects You have the ability to simultaneously manage a few complex large projects or several diverse small projects<p> <p><b>Qualifications<b> <p><p><strong>Required Skills<strong><p> <ul><li>A bachelors degree in a relevant engineering field civil mechanical electrical chemical or other or construction management<li> <li>A masters degree or higher in business or a relevant field is preferred but not required<li> <li>Minimum of 10 years of capital portfolio and major project management experience including 7+ years experience in pharmaceutical and global roles<li> <li>Proven project management and technical knowledge with a demonstrated ability to deliver safe effective and fully compliant projects<li> <li>Demonstrated leadership abilities leading capital execution teams in a matrix capacity<li> <li>Excellent communication skills with the ability to effectively present complex ideas and solutions to executive management and technical experts<li> <li>Demonstrated knowledgeunderstanding of key nontechnical business processes human relations and finance<li> <li>Advanced HSE and GxPQA knowledge<li> <ul><p><strong>Desired Skills<strong><p> <ul><li>Experience with EcoSys or a similar project management tool<li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Manager, US Transparency Reporting (Principal Business Analyst, Transparency Reporting)
Company: Biogen
Location: Cambridge
Posted Mar 14, 2024
<p><b>Job Description<b> <p><p> Work on large crossfunctional projects that involve business process automation requiring system and data integration by interacting with stakeholders to identify gather analyze refine and maintain business requirements<p> <p> Lead requirement discussions to document analyze and translate functional and nonfunctional business requirements into project specifications business process diagrams and workflows<p> <p> Develop Requirements and Traceability Matrices for projects to ensure that all approved requirements are delivered and tracked back to a business objective<p> <p> Monitor and manage project execution to ensure adherence to budget schedule scope milestones and deliverables<p> <p> Assess current or future customer needs and priorities by communicating directly with customers conducting surveys or other methods<p> <p> Ensure business value is defined and can be measured post deployment<p> <p> Apply best practices from IT Project Management methodologies Agile Waterfall or hybrids<p> <p> Work with the application development teams to help translate requirements into technical specifications<p> <p> Provide strong support during the build process overseeing development to ensure the solutions are built and will meetexceed the needs of the business assist in system testing<p> <p> Oversee Change Management with business partners from a system use perspective identify and address business process touchpoints<p> <p> Define the user experience ensuring solutions that not only work but are easy to navigate and consume<p> <p> Deliver a rich user experience via ProofofConcept iterations and agile prototyping<p> <p> Facilitate the UAT process working with end users to define test scenarios plans and test scripts<p> <p> Ensure the business fully understands the capabilities and tests the complete solution and data supporting it<p> <p> Assist users during UAT and work with users and development teams on issues identification and resolution<p> <p> Prepare weekly status reports and identify and manage any risks issues and dependencies<p> <p> Effectively communicate and escalate issues roadblocks and risks to management while maintaining responsibility for their resolution to ensure the successful launch of each project<p> <p> Drive priorities and deadlines to completion<p> <p> Telecommuting permitted up to 100<p> <p><b>Qualifications<b> <p><p><u>Minimum Requirements<u><strong><strong><p> <p>Bachelors degree or foreign equivalent in Computer Science Electronics Engineering Information Science Management Information Systems or a related field and 5 years of experience in the job offered or in an Transparency Reportingrelated occupation<p> <p><br ><p><p>Position requires 48 months of experience in the following<p> <p> 4 years of project management experience related to web or software development<p> <p> Working knowledge of Sunshine Act transparency reporting and compliance<p> <p> Proven track record of delivering projects on time and in budget<p> <p> Proven ability to shape sell and lead delivery of complex and strategic IT advisory engagements<p> <p> Effectively driving execution and owning responsibility for overall success of projects and managing shifting priorities demands and timelines<p> <p> Developing and following complex communication plans project plans and providing updates to senior level executives<p> <p> Selecting and evaluating technical solutions that fit the need of an organization<p> <p> Supporting administrations in procuring new services from vendors by advising on tender procedures and IT outsourcing<p> <p> Building relationships with key Business Service owners and all IT staff to ensure that IT delivered services and enduser productivity goals are understood and exceeded<p> <p> Strong understanding of Digital Transformation and ability to translate business requirements into IT applications<p> <p> Strong knowledge of Veeva CRM<p> <p> Working knowledge of Business Intelligence tools and data warehouses<p> <p> Reviewing technical information and effectively communicating the information orally and in writing to internal and external stakeholders<p> <p><b>Additional Information<b> <p><p>All your information will be kept confidential according to EEO guidelines<p> <p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Specialist, Global Trade Compliance
Company: Biogen
Location: Cambridge
Posted Mar 11, 2024
<p><b>Job Description<b> <p><p><strong>About This Role<strong><br >The purpose of this role is to develop implement manage and advance Biogens Trade Compliance program for designated territories as well as develop oversee and manage Biogens trade compliance analytics capabilities globally This role is responsible for creating local and regional processes and systems facilitating trade optimizing duty programs ensuring compliance to trade controls such as Free Trade Agreements Customs Valuation HTS Classification restricted party screening and contract governance<br >Additionally this role will lead the Analytics COE supporting datadriven decisionmaking program monitoring and compliance optimization strategies Balancing these responsibilities the role requires crossfunctional coordination with logistics manufacturing finance tax IT operations excellence and other functions across Biogen business units and geographic landscape<br >Furthermore as a Subject Matter Expert this role will proactively identify advise and adapt processes and capabilities to emerging trade issues and changing regulatory landscape ensuring that Biogens global trade programs adhere to all applicable importexport regulations and facilitating business continuity You will represent Biogen with Customs Agencies and Trade Organizations for the designated territories to reduce trade related risks and enable Biogens strategic business objectives<p> <p><strong>What Youll Do<strong><br ><u><em>Global Trade Compliance Program<em><u><p> <ul><li>Develop implement manage and advance TC regulatory and operations program including establishing controls procedures and best practices <li> <li>Manage day to day trade operations of designated territories Set up and manage customs brokers of designated territories POA importexport clearance instruction QBR performance metrics Manage importexport licenses application process Monitor and mitigate trade compliance risks by conducting post entry audits and developing metrics <li> <li>Liaison between Biogen entities Customs and participating gov agencies <li> <li>Work closely with Distribution and Logistics and other internal partners to enable and streamline importexport and international distribution activities<li> <li>Proactively monitor anticipate and adapt trade compliance controls to emerging trade issues government and regulatory changes Implement compliant solutions to ensure business continuity <li> <li>Become SME for topics related to trade compliance operations in designated territories<li> <li>Due diligence assessments and contract governance oversight to enable product launches mergers and acquisitions and partnerships for the region <li> <li>Responsible for implementing and maintaining duty optimization programs eg Preferential programs import regimens trusted trader certifications etc <li> <li>Develop and deploy GTC training portfolio for cross border moves to increase and ensure awareness of trade compliance for stakeholders partners service providers etc<li> <ul><p><u><em>Global Trade Compliance Insight Driven Analytics COE<em><u><p> <ul><li>Develop foundational capabilities and manage TC Analytics best developed practices<li> <li>Global customs data collection data analysis optimization and reporting<li> <li>Develop system and analytics capabilities to proactively identify import requirements and import tax impact across different sourcing scenarios<li> <li>Develop system and analytics capabilities to manage efficient and sustainable Post Entry Audits and Annual risk assessments<li> <li>Build analytics capabilities and standardize practices to manage a single repository of Customs filings globally<li> <li>Work with regional and country leads to develop implement and maintain standard TC dashboard and scorecard including TC operations Broker Management and compliance KPIs <li> <ul><p><b>Qualifications<b> <p><p><strong>Required Skills<strong><p> <ul><li>University degree in a related field or equivalent experience certifications<li> <li>Minimum 2 years of trade compliance related work experience with Multinational Companies of regulated industries<li> <li>Solid knowledge of International Trade fundamentals HTS classification COO valuation Incoterm etc and customs and FDA compliance programs development<li> <li>Experience working with Oracles Global Trade Management or similar ERP trade compliance modules<li> <ul><p><strong>Preferred Experiences and qualifications<strong><p> <ul><li>US Licensed customs broker<li> <li>Experience working with US and other regions customs FDA and other government agencies<li> <li>Experience with BI tools and other data analytics software<li> <li>Technical knowledge and experience on business analytics risk mapping projects<li> <li>Project management experience<li> <li>Ability to work in a diverse global team with resources based across multiple countries <li> <ul><p><b>Additional Information<b> <p><p><strong>Why Biogen<strong><br >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<p> <p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Sr. Reliability Engineer I
Company: Biogen
Location: Raleigh-Durham, NC
Posted Mar 11, 2024
<p><b>Job Description<b> <p><p>The Sr Reliability Engineer I applies Reliability Engineering methodologies to optimize design requirements and performance of critical assets across the site Originates and develops analysis methods for determining reliability of components equipment and processes Acquires data and analyzes the data Prepares and communicates information to define reliability problems recommend improvements and avoid failures<p> <p>In addition this Sr Role partners with responsible engineers maintenance operations quality project engineers and other stakeholders to establish and execute reliability strategies throughout the Asset LifeCycle Champions and applies reliability tools such as Failure Mode and Effect Criticality Analysis Reliability Modeling and Prediction Reliability Growth Maintainability Availability and Root Cause Failure Analysis<p> <p><strong>What Youll Do<strong><p> <ul><li>Performs detailed analyses of site manufacturing and utilities process equipment to establish and implement reliability strategies RCM which minimizes failures or the impact of failures in the most costeffective manner<li> <li>Establish and manage Reliability KPIs for continuous improvement<li> <li>Work with Planner Schedulers and Partsroom Attendants to assure that Job Plans and Spares strategies are consistent with the Reliability strategies according to risk<li> <li>Consult with project teams and Responsible Engineers to establish reliability targets employ the appropriate reliability tools early in the lifecycle of new equipment and to establish measurable performance criteria to achieve reliability targets<li> <li>Lead or assist in Root Cause Analyses and failure investigations in support of deviations or safety events as necessary<li> <li>Work across multiple site functions to ensure the reliability and maintainability of new and modified installations<li> <li>Introduce state of the art tools to enhance the sites Reliability program<li> <li>Collaborate with other sites and Global functions to establish corporate standards and best practices in Reliability Engineering<li> <ul><p><b>Qualifications<b> <p><ul><li>BS in Engineering or related discipline + 46 years of manufacturing experience<li> <li>Experience leading Root Cause Failure Analyses Criticality Assessments FMEAs<li> <li>Experience with reliability modeling reliability growth analysis and allocation<li> <li>Competency MS Word MS Excel MS Power Point and MS Project MiniTab JMP or other Statistical analysis platforms<li> <li>Excellent oral and written communication skills<li> <li>Assignments are moderately complex in nature where ability to recognize deviation from accepted practice is required Judgment is required in resolving problems amp making routine recommendations <li> <ul><p><strong>Preferred Qualifications<strong><p> <ul><li>Experience in pharmaceutical or biotech manufacturing<li> <li>Practical knowledge and application of GMP and EMEA regulations<li> <li>Certified Reliability Engineer or Certified Maintenance and Reliability Professional<li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>
Director, Public Payer Strategy & Reimbursement Solutions
Company: Biogen
Location: Cambridge
Posted Mar 09, 2024
The Director, Public Payer Strategy & Reimbursement Solutions at Biogen will lead the development of innovative approaches for ensuring patient access to Biogen products, focusing on Medicare and Medicaid. This role involves working cross-functionally with various teams, evaluating potential risks, and developing strategies to adapt to state and federal policy changes. The ideal candidate should have a deep understanding of the US healthcare system, strong communication skills, and experience leading cross-functional teams.
Senior Engineer I, Fill Finish Technical Authority
Company: Biogen
Location: Raleigh-Durham, NC
Posted Mar 13, 2024
<p><b>Job Description<b> <p><p>The Fill Finish Engineering Technical Authority function as part of the Global Engineering and Facilities function is looking to hire an individual contributor who is accountable for subject matter expertise in fill finish engineering and technical operations as related to all Parenteral products manufactured At Biogen Subject Matter Expertise is demonstrated by possessing a comprehensive understanding of the complete asset lifecycle which includes performance design install CQV operation maintenance and reliability requirements This role and team effectively contribute and add value to all stages of the assets lifespan ensuring standards specifications strategic approach to manage the lifecycle of the asset ensure optimal performance efficiency and longevity <p> <p>This SME will have a fill finish aseptic and engineering body of experience a passion for innovation and the ability to build strong partnerships at all levels across the enterprise Parts Prep Compounding and Fill Line including Isolator technology is the primary focus of this role but overall support for Fill Finish end to end process is required <p> <p><em>This is a hybrid role to be based at our site in RTP NC <em><p> <p><strong>What Youll Do<strong><p> <ul><li>Be a subject matter expert on Fill Finish operations in particular frontend activities Parts Prep Compounding and Filling Line operations Identify and execute on Improvement projects in support of increased productivity efficiency and operations and ensure that design of equipment facility and process eliminates potential for contamination <li> <li>Benchmark relevant datainformation and translate into measurable improvements inhouse support the sites in troubleshooting investigation as needed and proactive identification of potential issues to ensure robust operation of the equipment and process Alignment with site engineering industrial engineering manufacturing and other site support functions on requirements and key metrics is key to ensuring cost effective efficient and robust operation of equipment and facility <li> <li>Functional activities to support CMObusiness development opportunities front end capital planning and execution of capital projects deliver engineering solutions driving cost effectiveness productivity efficiency safety quality compliance and without delay ensure that reliability is integrated into the design construction and operation of new and existing facilities equipment and systems <li> <li>Develop maintain improve fill finish engineering best practices standards and specifications<li> <li>Support as required our external CMO partners for Biogen products and processes<li> <ul><p><b>Qualifications<b> <p><ul><li>BS in Chemical or Mechanical Engineering or related process engineering discipline MS in engineering discipline is strongly preferred but not required <li> <li>A minimum of 6 years experience in Fill Finish Engineering in Biotech Pharma or equivalent industry experience<li> <li>Detailed knowledge of Fill Finish technical operations including related asset lifecycle management practices specifically engineering facility best practices reliability engineering engineering document management computerized maintenance management and commissioning qualification validation <li> <li>Detailed knowledge and experience of Parts Prep CompoundingFormulation and Fill Line operations including Isolator technology Inspections systems manual and automatic an advantage <li> <li>Experience in projects design management including financial considerations and execution required <li> <li>Detailed knowledge and application of FDA and EMEA regulations <li> <li>Good organization communication and interpersonal skills are required as well as strong communication and presentation skills <li> <li>Ability to influence individuals at both site and global level <li> <li>Good understanding of asset lifecycle cycle and management <li> <li>Knowledge of other modalities eg Small Molecule APIOSD Finished Goods or Drug Substance would be an advantage but not required<li> <li>Experience in design of equipment and facilities from a contamination control perspective is desirable This may also include experience with an Architectural amp Engineering consultancy company<li> <li>Already established network of technical leaders peers and stakeholders in life science industry Actively participates in industry forums etc<li> <ul><p><strong>Who You Are<strong><p> <p>This individual should have a detailed understanding of Fill Finish manufacturing processes and equipment and a proven ability to apply hisher expertise to identify areas of opportunity and provide solutions for improvement Heshe should have experience working on projects specification and qualification of new or existing equipment within Fill Finish processes inline with current regulations and have demonstrated an ability to work collaboratively with crossfunctional teams to deliver results Demonstrated herhis ability to provide detailed scope of projects and support the process to obtain buyin from leaders and decision makers at senior and executive level Ideally has experience in contamination control measures as related to engineering solutions and experience in developing and maintaining engineering specification documents<p> <p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>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<p> <p>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 DEampI efforts<p> <p>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 EVerify Employer in the United States<p>