Jobs at Biogen
25,826 open positions
Senior Manager, Quality Assurance Canada
Company: Biogen
Location: Other US Location
Posted May 24, 2024
The Senior Manager, Quality Assurance is responsible for ensuring compliance with technical and regulatory requirements for imported pharmaceuticals and biologic finished products in Canada. They oversee quality assurance activities, maintain Drug Establishment Licenses, and manage distribution partners. The role involves leading local Quality Management Systems, conducting audits and inspections, and ensuring product market release. The ideal candidate should have a Bachelor's degree in Health Sciences, extensive experience in QA/GMP roles, and knowledge of Canadian regulations for pharmaceutical and biologic products.
Network Engineer
Company: Biogen
Location: Raleigh-Durham, NC
Posted May 12, 2024
Biogen is seeking a Network Engineer to support the manufacturing control network infrastructure at their RTP location. The role involves day-to-day support of various devices, deployment and configuration, front-line support for manufacturing operations, and collaboration with other engineering teams. The ideal candidate should have a BA/BS in computer science or related field, at least 5 years of network engineering experience, and strong analytical and problem-solving skills. Experience with pharmaceutical production networks is preferred. Biogen values diversity and inclusion, and the role offers the opportunity to work in a fast-paced environment with a focus on neurological and rare diseases.
Sr. Director, Head of Data Management and Reporting Execution
Company: Biogen
Location: Cambridge
Posted Apr 26, 2024
<p><b>Job Description<b> <p><p><strong>What Youll Do<strong><br > Set direction for the Enterprise Data Strategy and Management team based on a comprehensive understanding across business units of the business challenges the business model the competitive environment and challengesopportunities as it relates to data strategy<br > Lead and inspire a team of direct reports to develop data strategy and governance aligned with and guided by sales marketing and payer business priorities and strategies<br > Build and foster a team that delivers value in partnership with each business unit across the enterprise ensuring policies and best practices exist and are followed for high data quality across systems<br > Foster personal development employee engagement and enhanced organizational culture<br > Owns the data accuracy quality amp governance for multiple business units accountable for supporting reporting analytics and the user community<br > Creates recurring reports for platform business and partners<br > Develops and executes on a data roadmap to profile prioritize develop validate and support for business unit<br > Responsible for leading collaboration between portfolio management reporting data architecture operations and data platforms to ensure successful deployment and maintenance of data assets<br > Serves as Data Steward champion and subject matter expert driving awareness understanding of the business unit data<br > Develops reference and education materials to promote the use of business unit data and master reference data<br > Gathers requirements and support standardization for data management to support reporting analytics and user community<br > Accountable for data quality rule identification and threshold review to ensure confidence within data and owns stakeholder communication when data quality alerts<br > Review and communicate findings clearly and concisely through narrativedriven presentations and effective data visualizations to executives and decisionmakers<p> <p><strong>Key Responsibilities<strong><br ><strong>Overarching<strong><br > Sets a clear vision and purpose for the US Data Strategy and Management team based on the priorities and needs of the US organization<br > Leads develops and executes US data strategy and governance process consisting of acquisition strategy contract management business rules quality stewardship reporting change management governance and communication plans<br > Acts as liaison communicating through reports meetings and memos the best use of data in each department from business owner to IT all the way to the consumer<br > Partners with Global Customer amp Data Analytics team Customer Excellence amp Operations teams all BUs and Payer regarding data access and appropriate tools<p> <p><strong>Governance<strong><br > Creates implements and manages data governance standards<br > Creates monitors and manages data policies and business rules ensuring enforcement through data governance standards<br > Develops and manages Governance KPIs<p> <p><strong>Quality<strong><br > Drives overarching data quality strategy through use of industry best practices<br > Develops and manages Governance KPIs<p> <p><strong>Automated Performance Reporting<strong><br > Ensures appropriate use of data and data quality of deliverables created by vendors<p> <p><strong>Acquisition strategy and management<strong><br > Develops data acquisition strategy directs data acquisition and consumption and the corresponding management of contracts and<br > Ownership and management of 3rd party data agreements<br > Management of team of individuals<br ><p> <p><b>Qualifications<b> <p><p><strong>Required Skills <strong><br > 15 years experience in Pharma data reporting and analytics function with depth in commercial data management related fields data managementgovernance data platform and business rules management business intelligence tools reporting platforms etc<br > 10+ years of experience in managing a Data Management team including responsibility for projects as well as hiring managing mentoring andor developing direct reports<br > 6+ years of experience in SQL Relational databases and Data Visualization tools such as Tableau Power BI etc<br > Strong understanding of specialty brand data and patient support services data including experience working with specialty pharmacy ie dispense status etc syndicated vendor ie Claims Rx and patient service center data ie patient enrollmentintake benefits investigation amp verification adherence programs<br > Experience managing an external data warehouse partner preferred and vendor management<br > Experience working with key commercial data providers such as IQVIA Symphony Komodo Veeva and MMIT<br > Experience implementing and managing data within a specialty pharmacy distribution model<br > Demonstrated expertise in handling patientlevel data and familiarity with HIPAA laws<br > Knowledgeable in the principles of data governance and date stewardship data quality<br > Demonstrated ability to attract talent and develop future leaders focused on achieving results with effective communication and influence skills<br > Experience managing direct reports including first line leaders and leading a productive team<br > Strong leadership and influence skills to advance the business<br > Strong verbal and written communication presentation skills <br > Ability to communicate effectively with executives and understand the complexity of their decision making<br > Demonstrated proficiency in matrix management and building relationships to gain trust and drive organizational change<br > Experience in AWS and Snowflake or other cloudbased data solution as well as Master Data Management MDM experience<br >Application of Knowledge<br > Leverage broad experience to set a clear vision for the team<br > Leverage past team leading experience to mentor coach first line leaders and individual team members and develop strong talent<br > Gain support from stake holders through effective communication and relationship building<br > Apply management skills to optimize the usage of team resources<br > Apply knowledge of analytic applications and best practices to drive organizational change to embed analytics for improved decision making<br >Problem Solving<br >Advanced problem solving skills are required to anticipate stakeholder and customer needschallenges to lead and inspire the team to develop appropriate business processes that can be embedded into the business<br > Set direction for the Enterprise Data Strategy and Management team based on a comprehensive understanding across business units of the business challenges the business model the competitive environment and challengesopportunities as it relates to data strategy<br > Lead and inspire a team of direct reports to develop data strategy and governance aligned with and guided by sales marketing and payer business priorities and strategies<p> <p>Bachelors degree required Masters preferred<p> <p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>We are a global team with a commitment to excellence and a pioneering spirit As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging medicines with every role playing a vital part in our mission Caring Deeply Achieving Excellence Changing Lives<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> <p><br ><p>
Head of Capital Management
Company: Biogen
Location: Raleigh-Durham, NC
Posted May 12, 2024
Biogen is seeking a seasoned professional with 15+ years of experience in portfolio management, project management, project engineering, and project controls in the pharmaceutical industry. The role involves leading the Capital Management function, managing a global large capital portfolio, and executing front-end planning processes. The ideal candidate should have a proven track record in delivering safe, effective, and compliant projects, and possess strong leadership and communication skills. Biogen values diversity and inclusion, and offers a mission-driven work environment focused on finding therapies for neurological and rare diseases.
Sr. Associate II, Site Services Specialist
Company: Biogen
Location: Raleigh-Durham, NC
Posted Apr 25, 2024
The Facilities Site Services Sr. Associate II, Property Administration Specialist is responsible for maintaining Biogen's buildings and rented spaces, including GMP cleaning, pest control, contractor program oversight, and ensuring the site is in a Fit for Manufacturing state. The role requires strong GMP knowledge, advanced education, and five years of experience in the biotech industry. Biogen values diversity and inclusion, offering opportunities for growth and impact in a mission-driven environment.
Sr. Territory Business Manager, MS Franchise - DC/Bethesda
Company: Biogen
Location: Washington DC
Posted May 11, 2024
Biogen is seeking a Sr. Territory Business Manager for a field-based specialty sales representative position. The role involves selling Neurology products, particularly to Neurologists, allied health professionals, and local MS chapters. The territory covers DC and surrounding cities. Key responsibilities include conveying complex clinical and reimbursement information, utilizing interpersonal skills to address customer needs, and collaborating with cross-functional peers. Qualifications include a BS/BA, 3-5+ years of pharma sales experience, a proven track record of success, and a customer-focused mindset. The base compensation range is $128,200 to $185,900, with additional benefits and incentives. Biogen values a culture of inclusion and excellence, offering opportunities for growth and impact.
Engineer/Associate Scientist, Oligonucleotide Purification Development
Company: Biogen
Location: Cambridge
Posted Apr 26, 2024
<p><b>Job Description<b> <p><p><strong>About This Role<strong><p> <p>We are seeking a highly motivated and creative individual with some process development experience to join our Oligonucleotide Purification Development team This position provides an exciting opportunity to develop robust high purity state of the art processes for the purification of oligonucleotides This position provides an exciting opportunity to gain handson experience and exposure to the design and development of manufacturing processes for clinical and commercial therapeutics<p> <p>This engineerassociate scientist role in the oligonucleotide development modality is responsible for purification development including process development process characterization scaleup for all unit operations chromatography detritylation UFDF with some guidance This position is expected to learn our oligonucleotide platform while exploring nonplatform and novel purification steps have a working knowledge of the manufacturing facilities and equipment contribute to tech transfer activities document review provide onthemanufacturing floor support troubleshooting and authoring CMC section of INDs These activities can include early and latestage process characterization and robustness studies<p> <p>This position will act as a subject matter expert on purification processes to facilitate interactions internally within the oligonucleotide organization synthesis drug product analytical as well as cross functionally with ResearchManufacturingMS project and tech transfer teams <p> <p><em>This an onsite role based at our headquarters in Cambridge MA <em><p> <p><strong>What Youll Do <strong><p> <ul><li>Develop and characterize purification processes for a rapidly expanding pipeline of new oligonucleotides drug therapies The individual will utilize multiple modes of chromatography and ultrafiltration and learn chemical cleavageconjugationhybridization steps<li> <li>Investigate new purification technologies that seek to enhance purity process robustness andor productivity of our existing oligonucleotide platform process<li> <li>Collaborate crossfunctionally with other groups to improve process understanding and manage team activities<li> <li>Document laboratory work in development reports trainingmentoring of new employees and lead pilot scale activities<li> <li>Scaleup and technology transfer oligonucleotide processes into our pilot and GMP manufacturing facilities and participate in writing regulatory sections for INDs <li> <ul><p><b>Qualifications<b> <p><p><strong>Who You Are <strong><p> <p>We are looking for someone who is passionate for exploring novel scientific ideas and play a key role in developing new cuttingedge technologies with a vision to push Biogens stateofart science in oligonucleotide purification that can ultimately impact patient lives You should have the ability to write development reports help lead pilot scale activities and collaborate across teams You should be able to work independently eg root cause investigations evaluation of processes with some guidance from the supervisor<p> <p><strong>Required Skills<strong><p> <ul><li>Bachelors degree in Biochemistry Chemical Engineering or related life science field with 24 years industry experience or masters degree with 02 years of industry experience is required<li> <li>Proven record of successfully planning and executing projects and experiments<li> <li>Demonstrated technical proficiency and creativity in developing innovative technologiesapproaches in purification<li> <li>Lab experience in purification of proteins andor DNARNA using column chromatography eg Ion exchange Hydrophobic Interaction andor Reversed phase and UFDF<li> <li>Some handson experience in analysis of proteins or DNARNA preferably using both HPLC and UVVis spectroscopy Experience using AKTA purification systems and Unicorn software and use of statistical design DoE are a plus Experience in statistical analysis is also a plus<li> <li>Motivated to work and communicate both individually and within teams<li> <ul><p><b>Additional Information<b><br ><p><p><p> <p><strong>Why Biogen<strong><p> <p>We are a global team with a commitment to excellence and a pioneering spirit As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging medicines with every role playing a vital part in our mission Caring Deeply Achieving Excellence Changing Lives<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> <p><br ><p>
Scientist II, Analytical Development- Oligonucleotides
Company: Biogen
Location: Cambridge
Posted May 10, 2024
Biogen is recruiting for a Scientist II position in its Oligonucleotides Analytical Development organization. The role involves developing state-of-the-art analytical methods for oligonucleotide-based products, from pre-clinical to commercialization. The ideal candidate should have a background in oligonucleotide therapeutics and experience with liquid chromatography and mass spectrometry. Responsibilities include designing and executing analytical method development, maintaining instruments, and collaborating with various CMC teams. The position is on-site at Biogen's headquarters in Cambridge, MA.
Associate Director, Quality Assurance
Company: Biogen
Location: Raleigh-Durham, NC
Posted May 06, 2024
This role involves leading a Quality Assurance team in a pharmaceutical setting, managing compliance oversight activities, and ensuring adherence to regulatory requirements. The ideal candidate should have a Bachelor's degree in a relevant Life Sciences discipline, extensive experience in quality systems, and a strong foundation in leading Quality Assurance teams. Biogen offers a mission-driven environment with a focus on diversity, inclusion, and innovation.
Associate III, Quality Engineering
Company: Biogen
Location: Raleigh-Durham, NC
Posted May 12, 2024
The Quality Engineering (QE) Associate III role at Biogen's RTP facility involves overseeing key aspects of Quality Assurance, including reviewing and approving various documents and changes. The role requires a motivated QA expert with 3-5 years of industry experience, a strong understanding of FDA/EMA regulations, and excellent communication skills. The position offers opportunities for problem-solving, innovation, and teamwork in a mission-driven environment focused on neurological and rare diseases.
Senior Principal Statistician
Company: Biogen
Location: USA
Posted Apr 26, 2024
<br><br><div class=h3>Company Description<div><br><br><div class=h3>Job Description<div><p>The Senior Principal Biostatistician is responsible for leading study design and data analysis and providing the statistical expertise for company products within one or more therapeutic areas in clinical development HeShe act as independent SMT or RDPT Biostatistician provides statistical input in the scientific discussion participates in protocol development analysis plans and filereport specifications and reviews study setup activities including but not limited to randomization CRFs and serves as lead biostatistician assigned projects This person performs statistical analyses interprets statistical results and prepares clinical study reports including integrated summaries for submissions as appropriate Heshe also assists in preparation of responses to statistical issues arising in regulatory or other legal settings or from external development partners HeShe maintains liaison with clinical research personnel in order to identify and meet the statistical support required by the development strategy under the supervision of the Associate Director or Director HeShe also contributes to the longterm growth strategy of the department by participating in process improvement initiatives keeping abreast of the current statistical methodology development and providing mentorship to newjunior biostatisticians<p><p><strong>Principal Accountabilities<strong><p><p>1 Represent Biostatistics on Project or Study Teams provides statistical expertise to support clinical development objectives and strategy<p><p>2 Defines statistical methodology analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project trains and supervises contract statisticians and ensures the quality of their deliverables<p><p>3 Assists responses to addressing statistical issues are part of regulatory legal or other challenges to the companys products or processes may represent Biostatistics in key meetings as assigned<p><p>4 Serves as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceuticalBiotechnology industry<p><p>5 Participates in approved process improvement initiatives mentors newjunior biostatisticians keeps up to date current on statistical methodology and computing development Conducts modelling and simulations as needed<p><br><br><div class=h3>Qualifications<div><p>Who You Are <p><p>You are an experienced biostatistician with a thorough understanding of statistical principles and clinical trial designmethods and with experience in submission or responding to regulatory questions and with proven ability to develop creative statisticaltechnicalregulatory acceptable solutions to complex problems in the designanalyses of clinical trials You have leadership skills in effective communication proactive strategy thinking priority evaluations and team working <p><p>Qualifications<p><ul style=><li style=>PhD in BiostatisticsStatistics or equivalent with a preferred 3+ years relevant work experience or MS in BiostatisticsStatistics with a preferred 6+ years relevant experience<li><li style=>Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them<li><li style=>Ability to provide technical solutions to a wide range of difficult problems Solutions are innovative thorough and practicable and consistent with objectives<li><li style=>Working knowledge of medicalbiological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas<li><li style=>Conversant with SAS or other software programming and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations<li><li style=>Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis study reports and statistical components of regulatory submissions<li><li style=>Able to manage multiple projects simultaneously to manage conflicting priorities and to be flexible when priorities change<li><li style=>Able to write and present information effectively Demonstrates leadership skills with effective communication including being able to explain methodology and consequences of decisions in lay terms able to translate requests to meaningful and relevant hypothesesstatistical questions<li><ul><br><br><div class=h3>Additional Information<div><p>The base compensation range for this role is <strong>$123300 to $198800<strong> Base salary is determined by a combination of factors including but not limited to job related years of relevant experience internal equity and location of the job Additionally this role is eligible for participation in Biogens LTI grants and other incentive programs Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear shutdown and 401K participation and matching contributions<p><div><div><p><strong>Why Biogen<strong><p><p>We are a global team with a commitment to excellence and a pioneering spirit As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging medicines with every role playing a vital part in our mission Caring Deeply Achieving Excellence Changing Lives<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 <a href=httpsnam12safelinksprotectionoutlookcomurl=https3A2F2Fwwwbiogencom2Fresponsibility2Fdiversityinclusionhtmlampdata=05|01|dennismercier40biogencom|67adaf5a6edd4324716208db0dcd2182|7b7466bbfe1d47a0b9438ded565c8e54|0|0|638118946897044815|Unknown|TWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn03D|3000|||ampsdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX043Dampreserved=0 rel=nofollow>Read on<a> 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><p> <p><img src=httpsremotivecomjobtrack1909014blankgifsource=publicapi alt=>
Sr. Reliability Engineer I
Company: Biogen
Location: Raleigh-Durham, NC
Posted Apr 26, 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>We are a global team with a commitment to excellence and a pioneering spirit As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging medicines with every role playing a vital part in our mission Caring Deeply Achieving Excellence Changing Lives<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> <p><br ><p>