Key
Responsibilities:
• Independently perform GMP and non-GMP sample testing according to SOPs and document results using various separation science platforms such as HPLC/UPLC (Size exclusion chromatography, Ion exchange chromatography, reversed phase HPLC, and Hydrophilic Interaction Chromatography (HILIC) and a variety of detection modes.
• Support other analytical methodologies such as capillary electrophoresis and binding assays depending on project needs.
• Maintain a GMP compliant laboratory environment.
• Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.).
• Support analytical method qualification/validation. Support lab investigations and troubleshooting of methods as needed.
Basic qualifications
• Bachelor’s degree in Biochemistry, Analytical Chemistry, or related discipline with a minimum of 2 years of relevant experience in the biotechnology/pharmaceutical industry or a master’s degree.
Preferred Qualifications
• Experience in HPLC separation methods (Size exclusion HPLC, Reversed Phase HPLC, Ion exchange HPLC) and use of HPLC instruments with Empower 3 software. Knowledge of electrophoresis (e.g. capillary electrophoresis, cIEF) and binding assays.
• Experience with and/or knowledge of the regulatory requirements for early stage genomic medicine development including knowledge of appropriate control and testing strategies.
• Theoretical knowledge in biologicals (e.g. Chemistry of DNA, RNA, protein)
• Working experience in a GMP environment and ability to adhere to all appropriate GMP standards.
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