Associate III, Quality Control (Virology) - United States
|External Posting Title||Associate III, Quality Control (Virology)|
|Job Description||The Associate III, 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 management of day-to-day operations to ensure that viral clearance validation studies are completed in a timely, compliant fashion; authoring and/or reviewing the Adventitious Agents section of regulatory filings; oversight of outsourced cell bank testing; and procedures|
Summary of Key Responsibilities:
• Perform assays in support of viral clearance, validation studies, routine testing, and investigations, including TCID50/mL and in vitro adventitious virus assays .
• Support the timely completion of Process Biochemistry and viral clearance activities.
• Review PVR protocols and reports, as well as raw data, in support of viral clearance studies.
• Review and revise SOPs.
• Participate in laboratory support functions, including but not limited to, virus and cell bank preparation and characterization, maintenance of indicator cell lines, equipment/instrument validation and maintenance, and testing of cell lines
• Support the validation of new analytical instruments and technology in QC Virology
|Location||Research Triangle Park, NC, US|
• Minimum of 5 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
|Education||Bachelor's Degree in Science (e.g., Biology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related disciplines) with equivalent 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.
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