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Sr. Scientist, QC (Global Sr. Manager - Virology) Durham United States,  

Posted on : 11 April 2017

Project Description

External Posting TitleSr. Scientist, QC (Global Sr. Manager - Virology) Job DescriptionThe Senior Scientist, Virology, Quality Control Quality Control Manager is responsible for the oversight of key tactical and strategic aspects of the Global QC Virology group. Responsibilities include; hiring, supervision and development of personnel; authoring and/or reviewing the Adventitious Agents section of regulatory filings; and procedures; and supporting viral clearance validation studies. In addition, the Sr. Scientist may participate on asset subteams for late stage clinical and commercial programs as the SME. Responsibilities include, but are not limited to, effective 2-way communication between the Quality line functions and the Asset teams, project management of key Virology deliverables, as well as review of regulatory filings and approval of cell bank item specifications. The Sr. Scientist is responsible for the technical oversight of viral clearance validation studies, as well as cell bank testing at CLOs, and provide support to the internal QC Virology groups in RTP and Hillerod. Summary of Key Responsibilities: • Development of key strategic directions for Global Virology operations within Pharmaceutical Operations and Technology• Support viral clearance validation studies to ensure that they are completed in a timely, compliant fashion • Performs final Quality review of the CMC sections of the regulatory filings for all regulatory agencies, US, EU, and ROW. Participates in audits by regulatory agencies Oversight of outsourced cell bank testing • Participates effectively on cross-functional teams as needed to support QC initiatives• Facilitates the execution of item specification approval, investigations, change control, manufacturing process validation and transfer, method adaptation/validation, as well as other Quality related activities in collaboration with their Asset (CMC) team and Quality Asset sub team. *LI-CTL2 LocationResearch Triangle Park, NC, US Job CategoryQuality Requisition Number30213BR Qualifications• Minimum of 15 years experience in Virology laboratories in the Pharmaceutical industry, •• Strong oral and written communication skills are a must• Strong interpersonal skills• Critical skills include: good organizational skills, strong communication skills, and ability to work with multiple teams with appropriate attention to detail• Knowledge of GMPs and global quality systems •• Knowledge of FDA/EMA regulations • Knowledge of virology methods and the ability to analyze data • Experience in Trackwise, Oracle, and myCIMS would be helpful EducationPhD. in Virology strongly preferred About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer s Disease, amyotrophic lateral sclerosis (ALS), Parkinson s disease, spinal muscular atrophy and neuropathic pain amongst others. With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. 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: Scientific, Bank, Banking, Database, Oracle, Engineering, Finance, Technology


Research Triangle Park, NC, US

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