Cambridge, Massachusetts, United States · Hybrid
$184k–$253k/yr
About This Role: As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product quality aspects within Biogen’s biologics portfolio. Your role will encompass stra…
Skills: Biologics Quality Management, People Management, Project Management, GMP Compliance, Regulatory Submissions
Research Triangle Park, North Carolina, United States · On-site
$65k–$72k/yr
About this role This role provides hands-on engineering support for manufacturing and facilities operations within a rotating engineering environment. The Engineer II supports drug substance manufacturing equipment acros…
Skills: Technical Troubleshooting, Equipment Lifecycle Management, Validation Activities, Capital Projects, Technology Transfers
Research Triangle Park, North Carolina, United States · On-site
$81k–$105k/yr
Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a hig…
Skills: Microbiological Testing, Environmental Monitoring, Utilities Monitoring, LIMS, Aseptic Techniques
Research Triangle Park, North Carolina, United States · On-site
$23/hr–$34/hr
About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:0…
Skills: Aseptic Technique, Cell Culture, Bioreactor Preparation, cGMP, SOP Compliance
Warsaw, Masovian Voivodeship, Poland · Hybrid
$106k–$142k/yr
About This Role: As an External Stakeholder Engagement (ESE) Senior Analyst, you will play a pivotal role within the GBS ESE and Sponsorship team. Your primary responsibility will be to manage and provide operational gui…
Skills: English Fluency, German Fluency, Stakeholder Engagement, Sponsorship Management, Operational Guidance
Seoul, South Korea · Hybrid
As Marketing Manager, you will be reporting to the NMD Business Unit Lead, you will lead the development and execution of brand strategies and integrated marketing plans for the Korea NMD portfolio, including SMA and ALS…
Skills: Brand Strategy, Integrated Marketing Planning, Market Insight Generation, Product Launch, Lifecycle Management
Baltimore, Maryland, United States · Remote OK
$165k–$239k/yr
About this role The (Senior) Medical Science Liaison role is a part of US Medical Affairs, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meanin…
Skills: Stakeholder Engagement, KME Relationship Management, Scientific Communication, Medical Insights Reporting, Veeva
Cambridge, Massachusetts, United States · Hybrid
$191k–$263k/yr
About This Role: As the Head of Procurement IT, you will lead the Procurement IT team and report to the Senior Director of Accounting, Procurement & Global Business Services (GBS) IT. Your primary responsibility will be …
Skills: Strategic Thinking, Stakeholder Management, Team Leadership, Project Management, Contract Negotiation
Los Angeles, California, United States · Remote OK
$165k–$239k/yr
About this role The (Senior) Medical Science Liaison role is a part of US Medical Affairs, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meanin…
Skills: Stakeholder Engagement, KME Relationship Management, Clinical Narrative Communication, Medical Insights Reporting, Veeva
Research Triangle Park, North Carolina, United States · On-site
$81k–$105k/yr
This is a full time on-site position with M-F business hours About This Role The Sr. Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen…
Skills: Batch Record Review, CAPA, Root Cause Analysis, GxP Regulations, Quality Management Systems
Research Triangle Park, North Carolina, United States · On-site
$25/hr–$40/hr
About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:0…
Skills: Upstream Cell Culture, cGMP, Standard Operating Procedures, Good Documentation Practices, Aseptic Processing
Research Triangle Park, North Carolina, United States · On-site
$25/hr–$40/hr
About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on nights (6…
Skills: Column Chromatography, Viral Filtration, Ultra-Filtration, Bulk Dispensing, cGMP
San Francisco, California, United States · Hybrid
$204k–$281k/yr
About This Role: As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of Biogen's nephrology assets. Your initial focus will be on overseeing a critical …
Skills: Matrix Management, CMC, Supply Chain Management, Life Cycle Management, Commercial Launch
Shanghai, Shanghai, China · Hybrid
Medical Manager for Immunology and Portfolio will lead from pre-launch to launch strategies development and medical activities for relevant pipelines and portfolios, including Business Development assets. This person wil…
Skills: Medical Affairs Strategy, Immunology, KME Engagement, Clinical Trial Coordination, Evidence Generation
Shanghai, Shanghai, China · On-site
This critical role is Biogen field medical force, working as a scientific expert in close collaboration with HCPs externally and cross- function deparments internally. In the meanwhile, this position will have opportunit…
Skills: Medical Science Liaison, KOL Management, Clinical Presentation, Scientific Communication, Medical Strategy
Madrid, Community of Madrid, Spain · On-site
TA to update Job Level: Internship Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-establi…
Skills: Talent Acquisition, Human Resources
Research Triangle Park, North Carolina, United States · On-site
$32/hr–$42/hr
Shift Information This position will work a 2,2,3 schedule working 12-hour DAY SHIFT from 6 AM to 6:00 PM. About the Job Provide customer-oriented service and support in a fast-paced manufacturing environment. Performs c…
Skills: Corrective Maintenance, Preventative Maintenance, GMP Documentation, Lock-out Tag-out, CMMS
Warsaw, Masovian Voivodeship, Poland · Hybrid
$106k–$142k/yr
About This Role: As a Source to Contract (S2C) Senior Analyst, you will be an essential part of the procurement team, focusing on operational sourcing and contract support. Your role involves ensuring a seamless user exp…
Skills: Procurement, Contract Management, Sourcing, RFx Process, Contract Lifecycle Administration
United States · Remote OK
$122k–$163k/yr
About This Role: As the Manager, Site Contracts Management, you will play a pivotal role in the execution of Clinical Trial Agreements between our company and study sites, ensuring seamless conduct of global clinical tri…
Skills: Site Contract Management, Clinical Trial Agreements, CRO Oversight, Budget Negotiation, GCP
Madrid, Community of Madrid, Spain · Hybrid
Biogen y el programa de Biorace Biogen es una compañía líder en biotecnología dedicada al desarrollo de tratamientos para enfermedades raras, inmunológicas y neurológicas. Con el objetivo de atraer y formar al mejor tale…
Skills: Medical Information, Data Analysis, Scientific Communication, Project Management, English Proficiency
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Lead the global product quality strategy for the biologics portfolio, ensuring alignment with GMP guidelines and company policies. Manage a team to oversee regulatory submissions, product specifications, and compliance across the product lifecycle.
Requires a Bachelor's degree and 12+ years of pharmaceutical experience, including 7 years in quality and 5 years in people management. Must possess extensive knowledge of GMP, GCP, GDP, and ICH regulations within an international matrix environment.
As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product quality aspects within Biogen’s biologics portfolio. Your role will encompass strategic, tactical, and operational management within the Product Development Quality (PDQ) department, ensuring that all quality-related aspects align with Biogen’s policies and GMP guidelines. You will facilitate the execution of activities between business partners, the CMC Asset Team, and the Quality organization, while empowering your team to drive innovation and best practices. Your leadership will ensure alignment across the portfolio, leveraging adjacent experience to lead teams on existing and new products and technologies. This pivotal position not only guarantees quality compliance but also develops the capabilities of your direct reports and broader organization in team management and quality issues. Your contribution is vital to maintaining our commitment to product excellence and innovation.
This is a hybrid role based either at our office in Research Triangle Park, NC or Cambridge, MA.
Lead asset strategy and compliance best practices across products within a modality.
Review major regulatory submissions and help set up regulatory strategic plans.
Develop and cross-train staff for maximum flexibility and growth.
Execute specification strategy for regulatory submissions and address agency concerns.
Collaborate with cross-functional teams to support product specifications and shelf-life strategy.
Serve as the Specification Review Board Chair and ensure cross-functional vetting of specifications.
Represent Biogen at external forums to stay abreast of emerging expectations and trends.
Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring.
Support internal audits, certifications, and external audits of CMOs.
Support combination product and device implementations in asset strategy.
You are an inspiring leader with a passion for quality and excellence in biologics. Your ability to empower and develop your team sets you apart as a mentor and coach. You thrive in collaborative environments, seamlessly integrating strategic vision with operational execution. Your innovative mindset drives you to tackle complex challenges, finding solutions that enhance product quality and compliance. You are adept at navigating cross-organizational relationships, influencing stakeholders, and fostering a culture of continuous improvement.
Bachelor’s degree and at least 12 years of experience in the pharmaceutical industry, with biological product development and/or production.
At least 7 years of experience in Quality associated with biopharmaceutical/pharmaceutical production.
Minimum of 5 years of experience in people management and project management.
Extensive knowledge in GMPs, GCP, GDP, ICH, and international regulations.
Experience in an international matrix environment.
Technical expertise in manufacturing, testing, or technical development.
Strong written and verbal communication skills.
Ability to influence partners and stakeholders with strong negotiation skills.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
