Scientist I, Analytical Technology (Clinical) - Two OpeningsApply now »
Date: May 2, 2017
Location: Research Triangle Park, NC, US
|External Posting Title||Scientist I, Analytical Technology (Clinical) - Two Openings|
|Job Description||***Please note that this posting represents two openings***|
The Analytical Technology Scientist I is responsible for leading the validation and transfer of in-process, release and stability test methods for clinical products to and from internal and external QC groups. Project management, timeline development, resource allocation, technical report authoring and review, exception resolution and statistical data evaluation are included in the scope of responsibilities for this position. The AT Scientist I supports regulatory by reviewing filings and authoring responses to regulatory agencies. The AT Scientist I also acts as a scientific resource to support method investigations. Other responsibilities include evaluation and implementation of new technologies in the QC labs. Strong technical writing and communication skills are required.
• Write, review, and sign off on technical protocols and reports. Review subsequent regulatory filings.
• Troubleshoot and/or optimize analytical methods for clinical and commercial programs.
• Independently create innovative solutions to complex technical and compliance issues.
• Identify, develop and implement new analytical technologies, coordinate and track activities of cross-functional multi-site teams to meet strategic goals and timelines.
• Lead and support troubleshooting for complex investigations in the QC labs and manufacturing investigations with an analytical component.
• Provide technical support for analytical method validation and transfer during regulatory inspections.
• Travel, as needed.
• Prepare and present scientific findings to broad audiences at department and site meetings and at external scientific conferences.
|Location||Research Triangle Park, NC, US|
• Bachelor of Science in Chemistry, Biochemistry, Biological Sciences or related field and 12 years GMP industry experience
• Masters or PhD in Chemistry, Biochemistry, Biological Sciences or related field and 1-5 years GMP industry experience
• Technical expertise in HPLC/UPLC, capillary electrophoresis and other biochemistry methods (LC-MS is a plus)
• Relevant authoring and execution experience in analytical method validation
• Demonstrated application and knowledge of ICH guidelines on analytical method validation
• Statistical experimental design and data analysis with JMP software
• Knowledge of stability indicating attributes for protein biotechnology products
• Experience training and mentoring others
• Excellent laboratory technique
• Excellent time management and prioritization skills
• Excellent oral and written communication skills
|Education||Bachelor of Science, Masters or PhD in Chemistry, Biochemistry, Biological Sciences or related field|
|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.
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.
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.
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