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Sr Associate I/II, Quality Control (Virology) - 2 openings Durham United States,
Posted on : 11 April 2017
|External Posting Title||Sr Associate I/II, Quality Control (Virology) - 2 openings|
|Job Description||***Please note that this posting represents two open positions***|
The Senior Associate, Virology, Quality Control is responsible for the oversight viral clearance validation studies, oversight of cell bank testing and other key tactical and operational aspects of the Global QC Virology group. Responsibilities include technical support to CLOs through collaboration with Biogen Contract lab management group to ensure that viral clearance validation studies as well as cell bank testing are completed in a timely, compliant fashion; authoring and/or reviewing the Adventitious Agents section of regulatory filings; and oversight of outsourced cell bank testing
Summary of Key Responsibilities:
• Provide technical support to to CLOs and internal virology groups functions,
• Provide support for validation studies, and investigations, including Q-RT-PCR, Q-PCR, end point PCR, TCID50/mL, and in vitro adventitious virus assays. Review assay books in support of in process testing.
• Review and compile data for reports
|Location||Research Triangle Park, NC, US|
• 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
|Education||Bachelor's Degree in Science (e.g., Biology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related disciplines) with equivalent experience:|
Sr. Associate I - Minimum of 5 years experience in Virology laboratories in the Pharmaceutical industry, with 7 years industry experience
Sr. Associate II - Minimum of 8 years experience in Virology laboratories in the Pharmaceutical industry, with 10+ years industry experience
|About Biogen||Biogen (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 "@biogen.com" email accounts.
Job Segment: Biochemistry, Biotech, Chemical Research, Engineer, Science, Quality, Engineering
Research Triangle Park, NC, US
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