Job Description:
The Scientist I, Analytical Technology, will lead the development and implementation of new methods that utilize Next Generation Sequencing (NGS) technology and real-time PCR in a cGMP laboratory environment. The successful candidate will engage across the broader organization to further develop the road map for implementing new molecular technologies such as NGS into the control strategy for biologics and gene therapy. The Scientist I will work closely with QC Virology to develop and implement real-time PCR and NGS methods for virus detection intended for routine QC testing. This includes working with cell culture and live virus using aseptic techniques, data analysis and interpretation of results generated from real-time PCR and NGS-based methods. Additional responsibilities include analytical method validation per ICH guidelines and analytical method transfers for both real-time PCR and NGS methods. Summary of Key Responsibilities: •Develop and implement both manual and automated NGS methods for Virology that are suitable for a cGMP laboratory •Data analysis for NGS methods, instruments and Bioinformatics reports •Design and execute both cell culture based and viral infection experiments and have excellent aseptic technique to prevent laboratory and instrument contamination in support of NGS and real-time PCR experiments •Subject matter expert for NGS during regulatory agency inspections and agency engagements •Author technical documents for method validation and method transfers in accordance with ICH guidelines •Lead and support method validation and transfer for both PCR and NGS based methods •Statistical design/analysis of analytical method validation and transfer protocols •Support lab efforts to generate and maintain NGS and PCR assay standards which may include generation of live virus stocks and DNA standards • Author SOPs for new analytical methods and instruments •Lead and support trouble shooting of both real-time PCR and NGS methodologies •Work closely with and train both AT and Quality Control (QC) analysts •Present projects to broad audiences, communicate updates, milestones, and roadblocks to senior management *LI-CTL2 Qualifications: • Technical expertise in Next Generation Sequencing (NGS), molecular detection of viruses, real-time PCR, virus stock production and mammalian cell culture • Project management, tracking and measurement • Excellent laboratory technique and experimental design • Experience working in a cGMP or regulated laboratory is a plus • Work independently with minimal supervision to meet aggressive or accelerated timelines • Strong oral and written communication skills are a must • Background in NGS data analysis and statistics is required • Knowledge of ICH guidelines on analytical method validation is desired • Experience training and mentoring others • Excellent time management and prioritization skills • Strong collaboration and organizational skills and an ability to work well in a team setting is required Education: Ph.D. Degree in Virology, Molecular Biology, Bioinformatics, Biology, Genetics or related discipline. Post-doctoral experience is desired
Additional Info:
The 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, and resolution of complex investigations. About Biogen Corporate 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. One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world. 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 "@biogen.com" email accounts. Location: Research Triangle Park, NC, US[Click Here to Access the Original Job Post]
The Scientist I, Analytical Technology, will lead the development and implementation of new methods that utilize Next Generation Sequencing (NGS) technology and real-time PCR in a cGMP laboratory environment. The successful candidate will engage across the broader organization to further develop the road map for implementing new molecular technologies such as NGS into the control strategy for biologics and gene therapy. The Scientist I will work closely with QC Virology to develop and implement real-time PCR and NGS methods for virus detection intended for routine QC testing. This includes working with cell culture and live virus using aseptic techniques, data analysis and interpretation of results generated from real-time PCR and NGS-based methods. Additional responsibilities include analytical method validation per ICH guidelines and analytical method transfers for both real-time PCR and NGS methods. Summary of Key Responsibilities: •Develop and implement both manual and automated NGS methods for Virology that are suitable for a cGMP laboratory •Data analysis for NGS methods, instruments and Bioinformatics reports •Design and execute both cell culture based and viral infection experiments and have excellent aseptic technique to prevent laboratory and instrument contamination in support of NGS and real-time PCR experiments •Subject matter expert for NGS during regulatory agency inspections and agency engagements •Author technical documents for method validation and method transfers in accordance with ICH guidelines •Lead and support method validation and transfer for both PCR and NGS based methods •Statistical design/analysis of analytical method validation and transfer protocols •Support lab efforts to generate and maintain NGS and PCR assay standards which may include generation of live virus stocks and DNA standards • Author SOPs for new analytical methods and instruments •Lead and support trouble shooting of both real-time PCR and NGS methodologies •Work closely with and train both AT and Quality Control (QC) analysts •Present projects to broad audiences, communicate updates, milestones, and roadblocks to senior management *LI-CTL2 Qualifications: • Technical expertise in Next Generation Sequencing (NGS), molecular detection of viruses, real-time PCR, virus stock production and mammalian cell culture • Project management, tracking and measurement • Excellent laboratory technique and experimental design • Experience working in a cGMP or regulated laboratory is a plus • Work independently with minimal supervision to meet aggressive or accelerated timelines • Strong oral and written communication skills are a must • Background in NGS data analysis and statistics is required • Knowledge of ICH guidelines on analytical method validation is desired • Experience training and mentoring others • Excellent time management and prioritization skills • Strong collaboration and organizational skills and an ability to work well in a team setting is required Education: Ph.D. Degree in Virology, Molecular Biology, Bioinformatics, Biology, Genetics or related discipline. Post-doctoral experience is desired
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Additional Info:
The 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, and resolution of complex investigations. About Biogen Corporate 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. One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world. 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 "@biogen.com" email accounts. Location: Research Triangle Park, NC, US[Click Here to Access the Original Job Post]