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Scientist I, Mass Spectrometry Analytical Technology Durham United States,  

Posted on : 15 April 2017

Project Description

External Posting TitleScientist I, Mass Spectrometry Analytical Technology Job DescriptionThe Analytical Technology (AT) group is a support function to the Quality Control (QC) groups, responsible for the evaluation and implementation of new technologies and improved analytical methods, validation and transfer of analytical methods, troubleshooting and resolution of complex investigations. The Scientist I, Mass Spectrometry, will provide expertise and knowledge in the validation and implementation of LC-MS methods for process monitoring and release of biotechnology products in a cGMP laboratory environment. This includes LC-MS methods for protein therapeutics and anti-sense oligonucleotides. The Scientist I will work closely with both Analytical Development and QC to develop and implement new methods and technologies that will be used for both process monitoring and routine QC release testing within Biogen and at vender CLOs. Main responsibilities include analytical method validation per ICH guidelines, QC readiness/implementation and analytical method transfers. The Scientist I will also be responsible for authoring the associated sections in regulatory filings and acting as the subject matter expert in regulatory inspections. Summary of Key Responsibilities: •Review and/or participate in development and/or qualification studies to design LC-MS methods for process monitoring and release testing that are suitable for a cGMP laboratory•Search and review the literature to develop a strong understanding for LC-MS instrument and method validation approaches•Purchase and set-up LC-MS instruments in a GMP lab• Author SOPs for LC-MS methods and instruments •Support the LC-MS GMP instrument (IOQ, PQ) and software validation studies ensuring part 11 compliance and data integrity•Design method validation experiments based on intended use per ICH guidelines•Author protocols and reports for method validation and method transfers with defined acceptance criteria in accordance with ICH guidelines•Develop appropriate statistical designs and perform statistical analysis of analytical method validation and transfer protocols•Subject matter expert for LC-MS methods during regulatory agency inspections and agency engagements•Collaborate with IT to develop LIMs interfaces for LC-MS methods used for GMP applications and release •Author associated regulatory filing sections and responses to agency questions•Collaborate with venders to resolve technical issues and evaluate options for GMP applications•Lead and/or support method transfers from Analytical Development to QC, other Biogen sites and vender CLOs•Lead and support troubleshooting and investigations related to LC-MS methods and technologies•Perform GMP testing and train AT and QC analysts to perform LC-MS methods•Provide technical support and troubleshooting for QC upon implementation•Prepare project updates to share with senior leadership team and present at staff meetings•Publish in scientific journals and/or present at scientific conferences•Understand industry and regulatory trends in order to develop business case for implementing LC-MS technologies for GMP activities•Collaborate with AD on comparability studies to support replacing traditional release tests and establishing appropriate release specifications LocationResearch Triangle Park, NC, US Job CategoryQuality Requisition Number31340BR Qualifications•Technical expertise and strong understanding of LC-MS applications in protein analysis is required; experience in oligonucleotide LC-MS methods is desired•Experience with a variety of MS methods such as peptide map/multi-attribute LC-MS, reduced intact mass for antibody characterization, and ion-pair HPLC UV MS •Excellent laboratory technique and experimental design•Experience working in a cGMP or regulated laboratory is a plus•Proficiency in data management and reporting of analytical results in various data systems such as Lab Information Systems (LIMS)•Work independently with minimal supervision to meet aggressive or accelerated timelines •Strong oral and written communication skills are a must•Knowledge of ICH guidelines on analytical method validation is desired•Excellent time management and prioritization skills •Strong collaboration and organizational skills and an ability to work well in a team setting is required EducationPhD or Masters in Chemistry, Biochemistry, Biological Sciences or related field and post-doctoral research or related industry experience is desired 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: Chemistry, Analytics, Biochemistry, Scientific, Biotech, Science, Engineering, Management


Research Triangle Park, NC, US

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