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Sr Associate I, Quality Control (Qualification Team) Durham United States,  

Posted on : 13 May 2017

Project Description

External Posting TitleSr Associate I, Quality Control (Qualification Team) Job DescriptionThe Sr Associate I is responsible for contributing to key functional, tactical and operational aspects of the QC qualification group. This includes leading and performing activities associated with qualification of standards, controls, and qualified reagents for use in QC testing and assessment of QC method performance. Such activities include coordinating, planning, executing qualifications, data management and analysis, and authoring/review/approval of associated qualification and method assessment documents. The Sr. Associate I should be proficient in analytical methods, and data analysis, and have the ability to serve as a technical expertise in bioassays/immunoassays (e.g. ELISA, cell based potency methods, AlphaScreen) and/or Biochemistry methods (electrophoretic techniques (e.g. SDS-PAGE, CE), chromatographic methodologies (e.g. RP-HPLC, SEC, IEC) with an understanding of method validation. Experience with techniques including antibody and protein purification and labelling (conjugation, biotinylation) and/or a working understanding of statistical analysis is not required but is a plus. The Sr. Associate I will also support QC Management for activities related to training and mentoring of employees in the team. The Sr. Associate I should demonstrated leadership abilities, strong presentation, oral and written communication skills; ability to communicate across all business areas and levels of the organization, strong organizational skills; ability to multi-task and coordinate multiple activities in parallel, and possess troubleshooting and problem solving skills. Candidate should be proficient in their understanding of cGMP, Quality Systems, have Knowledge of FDA/EMEA regulations and compliance and be able to apply that knowledge. A mature leadership approach is essential with an understanding of their personal communication style and manages these aspects effectively.•Coordinates/manages, and in some cases performs material qualifications (e.g. reagent qualifications), for standards (reference standard and secondary standards), controls, and reagents qualifications•Authors and reviews protocols and qualification reports, change controls, and may approve protocols and reports•Authors and reviews method assessment reports, and may approve reports •Provides technical oversight as a subject matter expert for the material qualifications and method assessments, including troubleshooting support •Data management and analysis for qualifications and method assessments•Interfaces with vendors, statisticians, and global teams to manage qualified material qualification and performance including leading teams, presentations, and ongoing communication•Supports internal and external audits•Actively provides leadership and mentoring as needed to team/peers and projects•Actively identifies gaps and areas for technical, process and quality improvement/innovation and leads/supports implementation*LI-CTL2 LocationResearch Triangle Park, NC, US Job CategoryQuality Requisition Number31003BR Qualifications•In depth knowledge of quality systems, validation with technical expertise in bioassays/immunoassays and/or Biochemistry methods•An understanding of standard, control, and critical reagent qualification•Excellent technical writing/presentation/communication skills•Data management•Statistical Analysis•Method validation•Research & development •Biological/Pharmaceutical drug processes•Leadership competencies including follow-up, decision making, communication, collaboration, problem solving, and innovation •In-depth understanding in area of work with exposure to multi- scientific disciplines, including how to apply effective quality systems Education5+ years of relevant experience (M.S. degree), 7+ years of relevant experience (B.S. degree) About BiogenCorporate Overview Through 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, Switzerland Our Science We 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 Citizenship The 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: Biochemistry, Biotech, QC, Pharmaceutical, Science, Quality


Research Triangle Park, NC, US

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