Biogen
At Biogen, we develop, market and manufacture therapies for people living with serious neurological, autoimmune and hematologic disorders.
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At Biogen, we believe diversity fuels excellence. Our organization has nearly 7,000 employees in over 30 countries, so we rely on these different perspectives to achieve business success, contribute to a healthier society, and bring unprecedented, innovative solutions to the patients and communities we serve.

Biogen Jobs

Sr. Manager, Medical Affairs Operations Process Innovation
SummaryThe Sr. Manager, Operations Process Innovation will be responsible leading the Medical Operations Process Improvement efforts.Job DescriptionThis role will engage across all functions of Medical Operations, with emphasis on root cause analysis, solution ideation, design and execution to drive operational effectiveness and efficiencies. Responsibilities will include:1. Plan, design, and manage the execution of Medical Operations Processes that promote operational efficiencies and process improvements. 2. Design, construct, and execute complex analyses to meet business case requirements using data that will often be self-sourced through observations, testing, interviews and custom data capture.3. Perform root cause investigation, problem solve, articulate conclusions, and make recommendations to the leadership team.4. Engage cross-functionally across the organization to design solutions, develop test and implementation plans, drive results, and resolve issues encountered by the team; including using your ability to assess and course-correct as necessary.5. Prepare material and presentations for the business in a way that adds value, is easily understood by others who may not have the same background or expertise, and improves the operational efficiency of the business.6. Communicate and influence at all levels of the organization.7. Foster regular communication and increases collaboration between the global organization with the regions and/or affiliates.8. Identify opportunities for standardization of the processes, training and metrics across the global organization.9. Identify and develop standard templates/toolkits related to processes, training and metrics for regional and/or affiliates to leverage. 10. Identify and share best practices across the global organization.The Sr. Manager, Process Innovation must possess strategic vision, excellent communication skills, proven motivational capabilities, have an executive presence, and a demonstrated track record of delivering results and achieving goals. This individual will work closely with functional leaders within Medical at the global and regional level to align on strategic priorities. He/she will develop and implement cross-functional process owner networks, ensuring ownership and multi-layered accountability, and with partners in IT, Development Sciences, Commercial, Public Affairs, Legal \u0026 Compliance to create firm linkages to essential functions. Competencies for this individual include: * Leadership: Establishing Strategic Direction, Driving Execution, Compelling Communications and a Global perspective* Functional/Technical: Complex Program Management, Business Process/System Improvement, Performance Improvement related experience, Operations Management, and Business Consulting. This is a highly visible role, which has high potential to impact all medical employees worldwide. This role requires strong leadership skills, knowledge of biopharma industry standards and practices and experience in Program Management. Candidates also must possess the ability to generate enthusiasm and followers, the ability to quickly gain trust and respect of peers and senior leadership, and a track record of successfully driving results through strong partnership with other functions and geographies.Qualifications6 -10 years of industry experience requiredInternational experience preferred as this is a global roleEducationMBA, M.A., M.S. preferredB.A. requiredProgram Management experience requiredAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Sr. Manager, Medical Affairs Operations Process Innovation
SummaryThe Sr. Manager, Operations Process Innovation will be responsible leading the Medical Operations Process Improvement efforts.Job DescriptionThis role will engage across all functions of Medical Operations, with emphasis on root cause analysis, solution ideation, design and execution to drive operational effectiveness and efficiencies. Responsibilities will include:1. Plan, design, and manage the execution of Medical Operations Processes that promote operational efficiencies and process improvements. 2. Design, construct, and execute complex analyses to meet business case requirements using data that will often be self-sourced through observations, testing, interviews and custom data capture.3. Perform root cause investigation, problem solve, articulate conclusions, and make recommendations to the leadership team.4. Engage cross-functionally across the organization to design solutions, develop test and implementation plans, drive results, and resolve issues encountered by the team; including using your ability to assess and course-correct as necessary.5. Prepare material and presentations for the business in a way that adds value, is easily understood by others who may not have the same background or expertise, and improves the operational efficiency of the business.6. Communicate and influence at all levels of the organization.7. Foster regular communication and increases collaboration between the global organization with the regions and/or affiliates.8. Identify opportunities for standardization of the processes, training and metrics across the global organization.9. Identify and develop standard templates/toolkits related to processes, training and metrics for regional and/or affiliates to leverage. 10. Identify and share best practices across the global organization.The Sr. Manager, Process Innovation must possess strategic vision, excellent communication skills, proven motivational capabilities, have an executive presence, and a demonstrated track record of delivering results and achieving goals. This individual will work closely with functional leaders within Medical at the global and regional level to align on strategic priorities. He/she will develop and implement cross-functional process owner networks, ensuring ownership and multi-layered accountability, and with partners in IT, Development Sciences, Commercial, Public Affairs, Legal \u0026 Compliance to create firm linkages to essential functions. Competencies for this individual include: * Leadership: Establishing Strategic Direction, Driving Execution, Compelling Communications and a Global perspective* Functional/Technical: Complex Program Management, Business Process/System Improvement, Performance Improvement related experience, Operations Management, and Business Consulting. This is a highly visible role, which has high potential to impact all medical employees worldwide. This role requires strong leadership skills, knowledge of biopharma industry standards and practices and experience in Program Management. Candidates also must possess the ability to generate enthusiasm and followers, the ability to quickly gain trust and respect of peers and senior leadership, and a track record of successfully driving results through strong partnership with other functions and geographies.Qualifications6 -10 years of industry experience requiredInternational experience preferred as this is a global roleEducationMBA, M.A., M.S. preferredB.A. requiredProgram Management experience requiredAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Sr Manager, Regulatory Affairs
SummaryThe Regulatory Affairs CMC Sr. Manager is a member of the Global Regulatory CMC team which provides regulatory strategic input and operational support to the cross-functional team within the Pharmaceutical Operations \u0026 Technology functions for Biogen's assetsThe role can be based in Cambridge (USA), RTP in North Carolina (USA), London Maidenhead (UK), Sao Paulo (Brazil), Zug (Switzerland)Job DescriptionThe Regulatory Affairs CMC Sr. Manager is a member of the Global Regulatory CMC team which provides regulatory strategic input and operational support to the cross-functional team within the Pharmaceutical Operations \u0026 Technology functions for Biogen's assets.This Regulatory CMC Sr. Manager will be responsible for actively contributing to the development and implementation of regulatory CMC strategy for Biogen's assets in mainly the Latin American Region, serving as the regulatory representative and/or leader on relevant project teams and initiatives, and serving as the regulatory contact with relevant regulatory authorities, as appropriate, whilst working flexibly across Global regions as demands require The role can be based in Cambridge (USA), RTP in North Carolina (USA), London Maidenhead (UK), Sao Paulo (Brazil), Zug (Switzerland)Essential Duties and Responsibilities:* Responsible for actively contributing to the development and implementation of pioneering and agile regulatory strategies, particularly for both biologicals and small molecules in development and registered in Latin America.* Responsible for coordinating regulatory submissions, both new MAA and post approval.* Work with partners to successful implement regulatory strategies* Assists in the identification and assessment of regulatory risks and mitigations plans.* Prepares and delivers effective presentations for internal audiences.* Contacts Regulatory Agencies, as appropriate.* Participates in Agency meetings as needed.* Accountable for product lead role, as required, and assists regulatory leads on relevant project teams.* Ethically supports Agencies, either directly, via trade associations or other means, to influence, develop and enhance regulatory guidelines.Additional:* Actively participates in and contributes to outside relevant conferences, including organizing and delivering presentations.* Assists in managing and takes steps to actively improve departmental systems and processes.* Assists in GMP inspections of Biogen sites or Biogen's third parties* Ability to assess regulatory impact of proposed CMC changes.QualificationsEssential:* Minimum 6-8 years pharmaceutical/biotechnology industry experience, 4+ years international CMC regulatory experience.( is this in line with the other snr mgr. listings? )* Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals and key milestones* Demonstrates strong communication and influencing skills, both internally and externally with peers in other departments and at partner organizations* Demonstrates solid organizational skills, including the ability to prioritize personal workload.* Strong interpersonal skills and the ability to influence effectively with diverse stakeholders, including R\u0026D, Global Quality, Engineering \u0026 Technology, Global Manufacturing, and external partners/collaborators* Demonstrates inclusive and effective cross-functional and cross-cultural skills to successfully drive regulatory strategies, especially in emerging markets* Demonstrates experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements at both pre- and post-approval stages.* Knowledge and understanding of applicable regulations.* Computer literate, and familiar with standard regulatory systems.Preferred/Additional:* Preferably experience with regulatory activities in Latin America and with Headquarters-led projects* Experience of managing international submissions.* Knowledge of development, manufacturing and analytical technology for both small molecules and biologicals.* Broad knowledge of local and international GMP requirements.EducationBA/BS/University degree required, Life/Health Sciences preferred.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Sr Manager, Regulatory Affairs
SummaryThe Regulatory Affairs CMC Sr. Manager is a member of the Global Regulatory CMC team which provides regulatory strategic input and operational support to the cross-functional team within the Pharmaceutical Operations \u0026 Technology functions for Biogen's assetsThe role can be based in Cambridge (USA), RTP in North Carolina (USA), London Maidenhead (UK), Sao Paulo (Brazil), Zug (Switzerland)Job DescriptionThe Regulatory Affairs CMC Sr. Manager is a member of the Global Regulatory CMC team which provides regulatory strategic input and operational support to the cross-functional team within the Pharmaceutical Operations \u0026 Technology functions for Biogen's assets.This Regulatory CMC Sr. Manager will be responsible for actively contributing to the development and implementation of regulatory CMC strategy for Biogen's assets in mainly the Latin American Region, serving as the regulatory representative and/or leader on relevant project teams and initiatives, and serving as the regulatory contact with relevant regulatory authorities, as appropriate, whilst working flexibly across Global regions as demands require The role can be based in Cambridge (USA), RTP in North Carolina (USA), London Maidenhead (UK), Sao Paulo (Brazil), Zug (Switzerland)Essential Duties and Responsibilities:* Responsible for actively contributing to the development and implementation of pioneering and agile regulatory strategies, particularly for both biologicals and small molecules in development and registered in Latin America.* Responsible for coordinating regulatory submissions, both new MAA and post approval.* Work with partners to successful implement regulatory strategies* Assists in the identification and assessment of regulatory risks and mitigations plans.* Prepares and delivers effective presentations for internal audiences.* Contacts Regulatory Agencies, as appropriate.* Participates in Agency meetings as needed.* Accountable for product lead role, as required, and assists regulatory leads on relevant project teams.* Ethically supports Agencies, either directly, via trade associations or other means, to influence, develop and enhance regulatory guidelines.Additional:* Actively participates in and contributes to outside relevant conferences, including organizing and delivering presentations.* Assists in managing and takes steps to actively improve departmental systems and processes.* Assists in GMP inspections of Biogen sites or Biogen's third parties* Ability to assess regulatory impact of proposed CMC changes.QualificationsEssential:* Minimum 6-8 years pharmaceutical/biotechnology industry experience, 4+ years international CMC regulatory experience.( is this in line with the other snr mgr. listings? )* Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals and key milestones* Demonstrates strong communication and influencing skills, both internally and externally with peers in other departments and at partner organizations* Demonstrates solid organizational skills, including the ability to prioritize personal workload.* Strong interpersonal skills and the ability to influence effectively with diverse stakeholders, including R\u0026D, Global Quality, Engineering \u0026 Technology, Global Manufacturing, and external partners/collaborators* Demonstrates inclusive and effective cross-functional and cross-cultural skills to successfully drive regulatory strategies, especially in emerging markets* Demonstrates experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements at both pre- and post-approval stages.* Knowledge and understanding of applicable regulations.* Computer literate, and familiar with standard regulatory systems.Preferred/Additional:* Preferably experience with regulatory activities in Latin America and with Headquarters-led projects* Experience of managing international submissions.* Knowledge of development, manufacturing and analytical technology for both small molecules and biologicals.* Broad knowledge of local and international GMP requirements.EducationBA/BS/University degree required, Life/Health Sciences preferred.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Associate Director Global Process Automation and Manufacturing Systems
SummaryResponsible for all process automation systems and manufacturing execution systems used at Biogen to support Pharmaceutical Operations and Technology (PO\u0026T). Responsible for managing a global group of engineers accountable for the development, implementation and operational support of the next generation manufacturing execution philosophy and associated computerized systems for all batch processing activities.Job DescriptionThis leader in the global process automation group at Biogen is responsible for all process automation systems and manufacturing execution systems used at Biogen to support Pharmaceutical Operations and Technology (PO\u0026T). Duties include:* Responsible for managing a global group of engineers accountable for the development, implementation and operational support of the next generation manufacturing execution philosophy and associated computerized systems for all batch processing activities.* Develops and implements global standards for process automation and MES software configurations, design specifications, new control strategies and software test protocols in support of new products, processes and systems. * Develops and implements global standards for control system and network hardware design, implementation and qualification. Ensures a robust strategy so that the above can be leveraged across sites. * Develops, implements, maintains and governs S95/S88 Standards, Libraries, Interfaces \u0026 Systems, including:*\tMaster Process Data*\tRecipe Libraries - Enterprise Recipe Management, through Development and Manufacturing*\tProcess Control (Level 1-2)*\tManufacturing Execution \u0026 Historian (Level 3-4)* Develops and Manages a global team of 4 - 8 Biogen engineers. Based on project demands, may need to manage large team of contract engineers through peak periods. * Develops and implements a comprehensive overall design for electronic batch records and automated batch record review by exception, suitable for implementation at multiple global sites. * Ensures compliance with all regulatory, environmental, health and safety guidelines.* Creates an environment where leadership and talent development are a top priority, resulting in a highperforming organization.* Creates and sustains a culture of innovation quality, compliance, accountability, employeeengagement, diversity and inclusion.* As this is a global role, international travel (up to 50%) is required. Extended travel during critical manufacturing operation start up phases is expected.Qualifications*\t10+ years' work experience, with at least 5 years related industry experience in a pharmaceutical,Biotechnology, drug development or equivalent environment. Experienceshould demonstrate track record of success and leadership positions of increasing responsibility.*\tDirect, relevant experience managing individuals and multi-disciplinary, global cross-functional teams. *\tSpecific experience in process automation, MES, batch manufacturing industrystandards (ISA S88 \u0026S95)*\tFormal or on the job experience in project management and strategic planning. Experience in Process Excellence methodology is desirable, but not required.*\tExcellent communication skills and a demonstrated ability to influence at all levels.*\tDirect experience designing, building, deploying and supporting automation and execution systems (Delta V/SCADA, Syncade MES, PAT, OSI Pi Data historian, etc.) in a regulated large scale pharmaceutical manufacturing environment.*\tExperience in running site-based shop floor systems in a globally distributed footprint is highly desirable.*\tProven experience in supporting highly automated/paperless new plant shakedowns, startups, commissioning \u0026 commercial support.*\tProficiency in maintaining computer network infrastructure.*\tExperience programming in DeltaV DCS. Knowledge of pharmaceutical/biotech manufacturing operations, through hands-on, on the floor experience.*\tExperience building, managing, and developing high performing, innovative and transformational process automation /execution systems across a global organization (US and EU).*\tA proven track record of influencing the industry on execution systems via publications and presentations is strongly preferred.EducationBachelor's Degree in a relevant Engineering discipline with a minimum of 10 years of related industry experienceAs this is a global role, international travel (up to 50%) is required. Extended travel during critical manufacturing operation start up phases is expected.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Associate Director Global Process Automation and Manufacturing Systems
SummaryResponsible for all process automation systems and manufacturing execution systems used at Biogen to support Pharmaceutical Operations and Technology (PO\u0026T). Responsible for managing a global group of engineers accountable for the development, implementation and operational support of the next generation manufacturing execution philosophy and associated computerized systems for all batch processing activities.Job DescriptionThis leader in the global process automation group at Biogen is responsible for all process automation systems and manufacturing execution systems used at Biogen to support Pharmaceutical Operations and Technology (PO\u0026T). Duties include:* Responsible for managing a global group of engineers accountable for the development, implementation and operational support of the next generation manufacturing execution philosophy and associated computerized systems for all batch processing activities.* Develops and implements global standards for process automation and MES software configurations, design specifications, new control strategies and software test protocols in support of new products, processes and systems. * Develops and implements global standards for control system and network hardware design, implementation and qualification. Ensures a robust strategy so that the above can be leveraged across sites. * Develops, implements, maintains and governs S95/S88 Standards, Libraries, Interfaces \u0026 Systems, including:*\tMaster Process Data*\tRecipe Libraries - Enterprise Recipe Management, through Development and Manufacturing*\tProcess Control (Level 1-2)*\tManufacturing Execution \u0026 Historian (Level 3-4)* Develops and Manages a global team of 4 - 8 Biogen engineers. Based on project demands, may need to manage large team of contract engineers through peak periods. * Develops and implements a comprehensive overall design for electronic batch records and automated batch record review by exception, suitable for implementation at multiple global sites. * Ensures compliance with all regulatory, environmental, health and safety guidelines.* Creates an environment where leadership and talent development are a top priority, resulting in a highperforming organization.* Creates and sustains a culture of innovation quality, compliance, accountability, employeeengagement, diversity and inclusion.* As this is a global role, international travel (up to 50%) is required. Extended travel during critical manufacturing operation start up phases is expected.Qualifications*\t10+ years' work experience, with at least 5 years related industry experience in a pharmaceutical,Biotechnology, drug development or equivalent environment. Experienceshould demonstrate track record of success and leadership positions of increasing responsibility.*\tDirect, relevant experience managing individuals and multi-disciplinary, global cross-functional teams. *\tSpecific experience in process automation, MES, batch manufacturing industrystandards (ISA S88 \u0026S95)*\tFormal or on the job experience in project management and strategic planning. Experience in Process Excellence methodology is desirable, but not required.*\tExcellent communication skills and a demonstrated ability to influence at all levels.*\tDirect experience designing, building, deploying and supporting automation and execution systems (Delta V/SCADA, Syncade MES, PAT, OSI Pi Data historian, etc.) in a regulated large scale pharmaceutical manufacturing environment.*\tExperience in running site-based shop floor systems in a globally distributed footprint is highly desirable.*\tProven experience in supporting highly automated/paperless new plant shakedowns, startups, commissioning \u0026 commercial support.*\tProficiency in maintaining computer network infrastructure.*\tExperience programming in DeltaV DCS. Knowledge of pharmaceutical/biotech manufacturing operations, through hands-on, on the floor experience.*\tExperience building, managing, and developing high performing, innovative and transformational process automation /execution systems across a global organization (US and EU).*\tA proven track record of influencing the industry on execution systems via publications and presentations is strongly preferred.EducationBachelor's Degree in a relevant Engineering discipline with a minimum of 10 years of related industry experienceAs this is a global role, international travel (up to 50%) is required. Extended travel during critical manufacturing operation start up phases is expected.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
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