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Associate II/III, Quality Control (Qualification Team) Durham United States,  

Posted on : 07 June 2017

Project Description

External Posting TitleAssociate II/III, Quality Control (Qualification Team) Job DescriptionThe Associate II/III is responsible for contributing to functional, tactical, and operational aspects of the QC qualification group at Biogen, RTP facility. This includes coordinating and performing activities associated with qualification of standards, controls, and qualified reagents for use in QC Bioassay testing, and activities associated with method assessments. Such activities include planning, coordinating, executing minimal qualification testing, data management and analysis, authoring and reviewing qualification protocols and reports, and authoring and reviewing method assessments. The Associate II/III should have an understanding of analytical methods, data analysis and interpretation, and have the ability to serve as a technical expert in bioassays/immunoassays (e.g. ELISA, cell based potency methods, AlphaScreen, etc.).Candidate should be proficient in their understanding of cGMP, Quality Systems, and have Knowledge of FDA/EMEA regulations and compliance and be able to apply that knowledge. The Associate II/III must have the ability to model the leadership competencies and work effectively independently, within a team framework, and across all business areas and levels of the organization. Principal Accountabilities: •Coordinates/manages, and in some cases performs qualification testing•Authors and reviews protocols and qualification reports, change controls•Authors and reviews method assessment reports•Provides technical oversight as a subject matter expert for the material qualifications and method assessments with minimal support•Data management and analysis for qualifications and method assessments•Interfaces with laboratory operations and other teams as appropriate for task•Actively identifies gaps and areas for technical, process and quality improvement/innovation and supports or lead through implementation*LI-CTL2 LocationResearch Triangle Park, NC, US Job CategoryQuality Requisition Number31360BR Qualifications•knowledge of quality systems•Understanding of method validation with technical expertise in bioassays/immunoassays •Statistical experimental design and data analysis with JMP and Excel Software•Excellent technical writing/communication skills•Data management •Biological/Pharmaceutical drug processes•Leadership competencies including follow-up, communication, collaboration, problem solving, and innovation EducationBiological Science degree is preferred with 3-5 years of relevant experience (MS degree) or 5+ years of relevant experience (BS degree) About BiogenCorporate OverviewThrough cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission:making a meaningful difference in the lives of patients with few or no treatment options.Biogen was founded in 1978 and today serves patients in nearly 70 countries. A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion Global headquarters in Cambridge, MA, and international headquarters in Zug, SwitzerlandOur ScienceWe aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.Biogen is revolutionizing biologics manufacturing, developing the industry s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.Our Corporate CitizenshipThe same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.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.Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Job Segment: Biotech, Pharmaceutical, QC, Laboratory, Science, Quality


Research Triangle Park NC US

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