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We work toward one goal: to improve the lives of people coping with serious disease. Getting there requires the coordinated efforts of many business areas, each with its own focus.

 

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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

Virtual Plant Manager, External Mfg
SummaryThe Virtual Plant Manager, External Manufacturing is responsible for managing specific Contract Manufacturing Organization(s). The incumbent's responsibilities would include commercial and/or clinical supply; leading one or several virtual plant teams; owning contract responsibilities and managing product(s) with one or more CMOs.Job DescriptionThe Virtual Plant Manager is responsible for direct communication with contract site management on production and production issues. Based on size, he/she may be the single management site lead or may have indirect reports helping in the management of production.The incumbent is expected to work closely with internal Biogen groups, and to coordinate the corresponding virtual plant team(s) (Quality, Planning, Logistics, Sourcing, Manufacturing Sciences, and Technical Development). Ensures continued supply of API / Drug Product / Finished Product as per clinical and/or commercial demand.Major responsibilities include:1. (20%) Primary contact and relationship manager to specified Contract Manufacturing Organization(s) for the entire relationship. For CMO(s) under her/his responsibility, this includes:*Managing contract setup, negotiation and maintenance (in collaboration with the Sourcing team);*Manage budget for contracted activities, including negotiation of initial and revised prices;*Establishing and/or maintaining the appropriate level of relationship;*Managing and solving potential disagreements, contract breaches etc.; *Assuring that interfaces between Biogen and CMO processes are functional and efficient. 2. (45%) For CMO(s) under responsibility, lead the cross-functional virtual plant teams consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members. In this role, assure:*On time and in full delivery of clinical and commercial products;*For clinical products, align Technical Development and CMO processes and expectations;*Resolution of operational issues e.g. deviations, corrective and preventive actions, production delays etc.;*Alignment of production planning with planned CMO production;*Follow-up of change control timely implementation in line with regulatory and stock management constraints;*Other operational aspects.3. (10%) Run the CMO governance team for CMO(s) under her/his responsibility:*Monitoring site performance according to standard KPIs;*Negotiate metrics targets with CMO based on governance team's input*Bringing CMO(s)' performance / maintaining it to Biogen's expectations;*Identifying quality / technical / business / EHS risks and related mitigation and corrective actions;*Ensure implementation of such actions at CMO(s) and Biogen4. (15%) Participate to or lead other matrix teams to drive projects, both internally and externally as they relate to the relevant API, Drug Product, device assembly or labelling and packaging operations. Such projects include technology transfers, process improvements, validation activities, packaging changes, regulatory submission reviews etc. and associate change management and/or project management. 5. (5%) Supports Sourcing activities in relation with CMO(s) under responsibility6. (5%) Acts as backup for the External Manufacturing lead for [Pharmaceutical Products] or [Parenteral Products] or [Device Assembly, Labelling and Packaging] or [Medical Devices, Diagnostics and New Platforms].7. Depending on the extent of the portfolio managed by the concerned CMO(s), the holder of the position may coordinate the work of one or more Production Leads, without direct management responsibility.Qualifications*Minimum 5 - 7 years of experience In biotech/pharmaceutical cGMP manufacturing industry. Experience with supplier relationship experience is a plus.*Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.*Good negotiation skills.*Ideally, experience with either biologics and oral solid dosage manufacturing including a mix of parenteral filling, API, oral solid dosage and finished products manufacturing.EducationBachelors/Master Degree (Life Science, Quality, Engineering), additional competences in Business Administration, Supply Chain or related fields are a plus.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
Virtual Plant Manager, External Mfg
SummaryThe Virtual Plant Manager, External Manufacturing is responsible for managing specific Contract Manufacturing Organization(s). The incumbent's responsibilities would include commercial and/or clinical supply; leading one or several virtual plant teams; owning contract responsibilities and managing product(s) with one or more CMOs.Job DescriptionThe Virtual Plant Manager is responsible for direct communication with contract site management on production and production issues. Based on size, he/she may be the single management site lead or may have indirect reports helping in the management of production.The incumbent is expected to work closely with internal Biogen groups, and to coordinate the corresponding virtual plant team(s) (Quality, Planning, Logistics, Sourcing, Manufacturing Sciences, and Technical Development). Ensures continued supply of API / Drug Product / Finished Product as per clinical and/or commercial demand.Major responsibilities include:1. (20%) Primary contact and relationship manager to specified Contract Manufacturing Organization(s) for the entire relationship. For CMO(s) under her/his responsibility, this includes:*Managing contract setup, negotiation and maintenance (in collaboration with the Sourcing team);*Manage budget for contracted activities, including negotiation of initial and revised prices;*Establishing and/or maintaining the appropriate level of relationship;*Managing and solving potential disagreements, contract breaches etc.; *Assuring that interfaces between Biogen and CMO processes are functional and efficient. 2. (45%) For CMO(s) under responsibility, lead the cross-functional virtual plant teams consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members. In this role, assure:*On time and in full delivery of clinical and commercial products;*For clinical products, align Technical Development and CMO processes and expectations;*Resolution of operational issues e.g. deviations, corrective and preventive actions, production delays etc.;*Alignment of production planning with planned CMO production;*Follow-up of change control timely implementation in line with regulatory and stock management constraints;*Other operational aspects.3. (10%) Run the CMO governance team for CMO(s) under her/his responsibility:*Monitoring site performance according to standard KPIs;*Negotiate metrics targets with CMO based on governance team's input*Bringing CMO(s)' performance / maintaining it to Biogen's expectations;*Identifying quality / technical / business / EHS risks and related mitigation and corrective actions;*Ensure implementation of such actions at CMO(s) and Biogen4. (15%) Participate to or lead other matrix teams to drive projects, both internally and externally as they relate to the relevant API, Drug Product, device assembly or labelling and packaging operations. Such projects include technology transfers, process improvements, validation activities, packaging changes, regulatory submission reviews etc. and associate change management and/or project management. 5. (5%) Supports Sourcing activities in relation with CMO(s) under responsibility6. (5%) Acts as backup for the External Manufacturing lead for [Pharmaceutical Products] or [Parenteral Products] or [Device Assembly, Labelling and Packaging] or [Medical Devices, Diagnostics and New Platforms].7. Depending on the extent of the portfolio managed by the concerned CMO(s), the holder of the position may coordinate the work of one or more Production Leads, without direct management responsibility.Qualifications*Minimum 5 - 7 years of experience In biotech/pharmaceutical cGMP manufacturing industry. Experience with supplier relationship experience is a plus.*Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.*Good negotiation skills.*Ideally, experience with either biologics and oral solid dosage manufacturing including a mix of parenteral filling, API, oral solid dosage and finished products manufacturing.EducationBachelors/Master Degree (Life Science, Quality, Engineering), additional competences in Business Administration, Supply Chain or related fields are a plus.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 III, Quality Control
SummaryThe Associate III is responsible for supporting, leading/participating in team initiatives regarding compliance, documentation, investigations, deviations, OOS/AR, systematic IA's, environmental excursions, and retest protocols.Job DescriptionThe Associate III is responsible for supporting, leading/participating in team initiatives regarding compliance, documentation, investigations, deviations, OOS/AR, systematic IA's, environmental excursions, and retest protocols. Drive CAPA, periodic review \u0026 change control activities, with the ability to approve and close CAPA. Mentor others in aspects of quality impact assessment (including QA \u0026 regulatory notification) quality systems, and risk assessment. Provides support and presents for internal \u0026 external regulatory inspections, as applicable. Approves AIV validation plan, summary and URS (requirements) documents, coordinates compendial review actions in AGILE, and LIMS oversight, as applicable. Keen understanding of the laboratory operations/testing process, equipment/instrumentation, and analytical test methods. Able to apply scientific understanding of validation \u0026 data analysis for reporting results.Works within own work group \u0026 spans across other work groups per project requirement. Responsible for managing assignments for self \u0026 team as determined by management. Prioritizing workload and helps to prioritize workload for team according to business needs. Draws upon experience, technical knowledge \u0026 compliance guidance to regularly contribute toward team decision making; able to represent the team and fosters team environment; Routinely contributes to and supports complex problem solving and manages noncomplex problem solving. Clearly communicates and supports management as well as key decisions/issues within team. Raises concerns to management, yet can get on board mutually once understanding rationale and supports decision moving forward. Champions improvement processes and supports self/team in meeting established measurable targets/goals. Proactively identify, communicate and monitor business changes that could impact quality or compliance within the department \u0026 across departments.QualificationsDemonstrated leadership abilities, strong presentation, oral and written communication skills; ability to communicate with management, peers and subordinates effectively, strong organizational skills; ability to multi-task and coordinate multiple activities in parallel. Demonstrated problem solving skills, demonstrated instrument/method troubleshooting skills, knowledge of FDA/EMA regulations and compliance. Broad knowledge of operations/quality systems/directives. Accountability for self and immediate work team through delivery of appointed deliverables. Excellent technical writing skills; authors technically-sound simple to moderately complex reports with complex reports with limited guidance. Actively participates in and often leads more complex projects. Proficient in their understanding of the quality systems and applies that knowledge within the team/project management routinely.Minimum Experience Requirements: 3+ years MS, 5+ years BS, in comparable/related roleEducationBachelor's degree (B.S.) in science discipline or Master's degree (M.S.)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 III, Quality Control
SummaryThe Associate III is responsible for supporting, leading/participating in team initiatives regarding compliance, documentation, investigations, deviations, OOS/AR, systematic IA's, environmental excursions, and retest protocols.Job DescriptionThe Associate III is responsible for supporting, leading/participating in team initiatives regarding compliance, documentation, investigations, deviations, OOS/AR, systematic IA's, environmental excursions, and retest protocols. Drive CAPA, periodic review \u0026 change control activities, with the ability to approve and close CAPA. Mentor others in aspects of quality impact assessment (including QA \u0026 regulatory notification) quality systems, and risk assessment. Provides support and presents for internal \u0026 external regulatory inspections, as applicable. Approves AIV validation plan, summary and URS (requirements) documents, coordinates compendial review actions in AGILE, and LIMS oversight, as applicable. Keen understanding of the laboratory operations/testing process, equipment/instrumentation, and analytical test methods. Able to apply scientific understanding of validation \u0026 data analysis for reporting results.Works within own work group \u0026 spans across other work groups per project requirement. Responsible for managing assignments for self \u0026 team as determined by management. Prioritizing workload and helps to prioritize workload for team according to business needs. Draws upon experience, technical knowledge \u0026 compliance guidance to regularly contribute toward team decision making; able to represent the team and fosters team environment; Routinely contributes to and supports complex problem solving and manages noncomplex problem solving. Clearly communicates and supports management as well as key decisions/issues within team. Raises concerns to management, yet can get on board mutually once understanding rationale and supports decision moving forward. Champions improvement processes and supports self/team in meeting established measurable targets/goals. Proactively identify, communicate and monitor business changes that could impact quality or compliance within the department \u0026 across departments.QualificationsDemonstrated leadership abilities, strong presentation, oral and written communication skills; ability to communicate with management, peers and subordinates effectively, strong organizational skills; ability to multi-task and coordinate multiple activities in parallel. Demonstrated problem solving skills, demonstrated instrument/method troubleshooting skills, knowledge of FDA/EMA regulations and compliance. Broad knowledge of operations/quality systems/directives. Accountability for self and immediate work team through delivery of appointed deliverables. Excellent technical writing skills; authors technically-sound simple to moderately complex reports with complex reports with limited guidance. Actively participates in and often leads more complex projects. Proficient in their understanding of the quality systems and applies that knowledge within the team/project management routinely.Minimum Experience Requirements: 3+ years MS, 5+ years BS, in comparable/related roleEducationBachelor's degree (B.S.) in science discipline or Master's degree (M.S.)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
Director, Alliance Management and Integration
SummaryThe Alliance and Integration Management Group is responsible for managing and optimizing the value of alliances and acquisitions across pharmaceutical product life cycle.Job DescriptionThe Alliance and Integration Management Group is responsible for managing and optimizing the value of alliances and acquisitions across pharmaceutical product life cycle. We are seeking a Director, Alliance Management and Integration to manage alliances and lead integration of acquired companies. The ideal candidate will have experience managing multi-program alliances, as well as experience integrating complex partnerships and acquisitions, "dis-integration" experience including carve-outs, divestitures and developing best practices. This role is highly cross-functional, requiring effective communication and collaboration with Biogen teams, alliance partners and respective leadership to achieve partnership, acquisition objectives. This position will be based in Cambridge, MA and report to the Vice President, Head of Alliance Management and Integration. Key responsibilities:* Work with new and existing partners to achieve partnership goals.* Lead efforts to establish mutual understanding, respect, trust and good communication between alliance partners.* Establish common understanding of the operational framework, drive governance bodies to ensure alliance progress and issue resolution per contractual mandate.* Ensure cross functional monitoring, coordination and mutual compliance with contractual obligations.* Develop partner insights: understand partner organization, decision making, interests. Facilitate mutual understanding of the respective organizations.* Proactively engage partners to manage issues, unexpected events, resolve conflicts at the lowest level. Drive process, decision making on renegotiations, alliance conclusion as appropriate. * Develop and execute integration strategy for acquired companies. Manage integration governance. * Develop alliance and integration success metrics and reporting tools.* Track and report health of the alliance, progress against key partnership objectives or key acquisition value drivers. Establish best practices.* Partner with Business Dev, legal and Project teams pre-deal to ensure project plans, value drivers for partnership/acquisition, governance are aligned appropriately in the contract* Foster alliance management understanding and skills across the organization.Qualifications* 10+ years in biotech, pharmaceutical, and/or consulting environments* Thorough understanding of contracts, partnerships, experience in negotiations, alliance management and /or M\u0026A integration* Track record of having managed successful alliances.* Experienced, hands-on project manager adept at establishing processes, defining "playbooks" and templates, and managing cross-functional teams through significant ambiguity and complexity* * Experience leading and/or significantly contributing to integration of acquisitions.* Strong general management and leadership qualities and an ability to influence across company lines and to communicate at the Executive Committee level.* Understanding of the drug development process and working knowledge of the essential activities for all key functional areas.* Excellent interpersonal, oral, and written communication skills, relationship building skills, ability to navigate organizations and with individuals at all levels.* Ability to manage difficult conversations and interactions as they arise. Ability to manage and resolve conflict; negotiation skills.* Strong analytical and leadership skills, including creative, problem solving mindset and ability to work in multicultural environment.* Highly motivated, results-oriented individual with passion for leveraging differences and doing right for patients.EducationBS/BA required; advanced degree (e.g., MBA) and/or advanced life sciences degree (MD, PhD, PharmD) strongly preferredAll 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
Director, Alliance Management and Integration
SummaryThe Alliance and Integration Management Group is responsible for managing and optimizing the value of alliances and acquisitions across pharmaceutical product life cycle.Job DescriptionThe Alliance and Integration Management Group is responsible for managing and optimizing the value of alliances and acquisitions across pharmaceutical product life cycle. We are seeking a Director, Alliance Management and Integration to manage alliances and lead integration of acquired companies. The ideal candidate will have experience managing multi-program alliances, as well as experience integrating complex partnerships and acquisitions, "dis-integration" experience including carve-outs, divestitures and developing best practices. This role is highly cross-functional, requiring effective communication and collaboration with Biogen teams, alliance partners and respective leadership to achieve partnership, acquisition objectives. This position will be based in Cambridge, MA and report to the Vice President, Head of Alliance Management and Integration. Key responsibilities:* Work with new and existing partners to achieve partnership goals.* Lead efforts to establish mutual understanding, respect, trust and good communication between alliance partners.* Establish common understanding of the operational framework, drive governance bodies to ensure alliance progress and issue resolution per contractual mandate.* Ensure cross functional monitoring, coordination and mutual compliance with contractual obligations.* Develop partner insights: understand partner organization, decision making, interests. Facilitate mutual understanding of the respective organizations.* Proactively engage partners to manage issues, unexpected events, resolve conflicts at the lowest level. Drive process, decision making on renegotiations, alliance conclusion as appropriate. * Develop and execute integration strategy for acquired companies. Manage integration governance. * Develop alliance and integration success metrics and reporting tools.* Track and report health of the alliance, progress against key partnership objectives or key acquisition value drivers. Establish best practices.* Partner with Business Dev, legal and Project teams pre-deal to ensure project plans, value drivers for partnership/acquisition, governance are aligned appropriately in the contract* Foster alliance management understanding and skills across the organization.Qualifications* 10+ years in biotech, pharmaceutical, and/or consulting environments* Thorough understanding of contracts, partnerships, experience in negotiations, alliance management and /or M\u0026A integration* Track record of having managed successful alliances.* Experienced, hands-on project manager adept at establishing processes, defining "playbooks" and templates, and managing cross-functional teams through significant ambiguity and complexity* * Experience leading and/or significantly contributing to integration of acquisitions.* Strong general management and leadership qualities and an ability to influence across company lines and to communicate at the Executive Committee level.* Understanding of the drug development process and working knowledge of the essential activities for all key functional areas.* Excellent interpersonal, oral, and written communication skills, relationship building skills, ability to navigate organizations and with individuals at all levels.* Ability to manage difficult conversations and interactions as they arise. Ability to manage and resolve conflict; negotiation skills.* Strong analytical and leadership skills, including creative, problem solving mindset and ability to work in multicultural environment.* Highly motivated, results-oriented individual with passion for leveraging differences and doing right for patients.EducationBS/BA required; advanced degree (e.g., MBA) and/or advanced life sciences degree (MD, PhD, PharmD) strongly preferredAll 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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