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US-WA-Seattle: Sr Scientist - QC Bioanalytical

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.


* BS/BA in Chemistry or related field with 4 years pharmaceutical and/or biotech laboratory experience * MS in Chemistry or related field with 2 years of pharmaceutical and/or biotech laboratory experience * Ph.D. in Chemistry or related field * Or Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.

Knowledge, Skills and Abilities:

* Effective communication and organizational skills. * Full knowledge of all data generation and statistical programs. * Full understanding and knowledge of separation science and general chemistry. * Proficient in operation and troubleshooting of a wide variety of analytical instrumentation and data acquisition systems. * 3-7 years experience in a regulated laboratory environment in the biotechnology or biologics industry; preferably in a GMP setting * Full understanding of cGMP requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance. * Proven analytical problem solving abilities * Technical writing skills * Ability to manage multiple tasks and priorities for successful project completion.

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