Date: 21-Aug-2012
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Sr Scientist - QC Bioanalytical
ESSENTIAL RESPONSIBILITIES
1. Perform chemical and biochemical analyses of in-process, bulk drug substance, drug product, and cell-based bioassays. SDS-PAGE, UV/Vis spectrophotometric and basic chemistry techniques also required.
2. Perform routine physical/chemical methods per USP/EP guidelines.
3. Author SOPs, analytical test methods, qualification/validation/study protocols and supporting reports.
4. Maintain close communication and interaction with QC management and staff to ensure on-time testing of samples.
5. Work closely with team members in a multi-functional environment to ensure and follow cGMP compliance in all laboratories areas.
6. Fully comply with company health and safety procedures and practices.
Education:
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BS/BA in Chemistry or related field with 4 years pharmaceutical and/or biotech laboratory experience
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MS in Chemistry or related field with 2 years of pharmaceutical and/or biotech laboratory experience
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Ph.D. in Chemistry or related field
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Or Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
Knowledge, Skills and Abilities:
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Effective communication and organizational skills.
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Full knowledge of all data generation and statistical programs.
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Full understanding and knowledge of separation science and general chemistry.
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Proficient in operation and troubleshooting of a wide variety of analytical instrumentation and data acquisition systems.
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3-7 years experience in a regulated laboratory environment in the biotechnology or biologics industry; preferably in a GMP setting
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Full understanding of cGMP requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance.
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Proven analytical problem solving abilities
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Technical writing skills
* Ability to manage multiple tasks and priorities for successful project completion.
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this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/