Senior Scientist (bioanalytical)
Location: Holly Springs North Carolina
Description: Novartis is presently looking of Senior Scientist (bioanalytical) right now, this career will be placed in North Carolina. Further informations about this career opportunity kindly see the descriptions. Job Purpose:
The individual in this role is responsible for leading Bionalytical development projects and activities including assay development, qualification, te! sting, and characterization of novel viral vaccine candidates. This role functions in both development and GLP/GMP setting.
Major Accountabilities:
- Subject matter expert in bioassay development. Require in-depth knowledge and hands on experi-ence on various methods of molecular biology, virology, and cell biology.
- Involve in design and implement analytical control strategy for viral vaccine projects.
- Develop and transfer of analytical release and characterization assays in support of viral vaccine, upstream and downstream process development, as well as subsequent transfer and implementa-tion of tests within QC labs for both Drug Substance (DS) and Drug Product (DP) development to support clinical trial studies and/or Commercial Manufacturing.
- Establish and execute deliverables for analytical assay development, qualification, tech transfer, and validation in collaboration with other groups or other sites; Ensure all de! liverables are within schedule and cost through proactive iden! tification of risks and mitigation steps.
- Plans and supervises multiple projects internally, at other sites and at external manufacturers test-ing requiring initiative and judgment.
- As a group leader, supervise junior scientists and/or the work of technical staff assigned to the project
- Prepare project update presentations for senior management reviews; contribute to regulatory filings and interactions with health authorities to ensure successful registration of products.
- Proactively identify potential issues. Develop creative solutions to technical problems in order to keep projects on schedule.
- Identify and evaluate new analytical technologies.
- Responsible for set-up, organization and strategic/technical/scientific direction of own work and for associates. Minimum requirements • Ph.D. with 6+ years’ experience or BS with 12+ years experience, MS with 10+ years experience in related science discipline.
- Degr! ee in Virology, Molecular Biology, Cell Biology, Biochemistry, or related major with relevant bio-technology/pharmaceutical development experience is preferred.
- At least 5 years of relevant work experience in new product development, tech transfer in the biotechnology, diagnostic, or vaccine industry.
- Hands on experience with a wide variety of bioanalytical methods (especially using SRID, ddPCR, qPCR, and/or FACS, etc.) to measure nucleic acid, proteins, virus like particles, viral gene vectors or other types of vaccines is preferred.
- Experience with Influenza vaccine development is a plus.
- Demonstrated leadership experience and ability to work with cross functional teams.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Novartis.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Sun, 28 Jul 2013 07:51:43 GMT