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Sr Scientist - QC Bioanalytical
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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