Scientist
2 weeks ago
RESPONSIBILITIES:
Perform HPLC/UPLC testing on In-Process, DS release, DP release, DS stability, DP Stability, process validation, analytical method validation/transfer, method establishment/qualification, and various other non-routine samples.
Demonstrate proper laboratory safety and housekeeping practices through weekly 5S Lab audits and monthly laboratory inspections. Assure all activities meet EHS requirements.
Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods (i.e.,Reverse Phase, SEC, Titer concentration, CEX, etc.).
Accurately record and report analysis results in accordance with lab procedures and quality systems.
Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions.
Maintain and troubleshoot analytical instrumentation and workspace as needed.
Perform method validation and/or qualification testing as needed.
Author and/or review SOP's, test methods, forms, and etc. in the document management system (eDMS).
Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
Work with internal and external customers to ensure clear and open communication is maintained when resolving and raising issues. Collaborate with QC leads, PM’s, and clients to maintain good health of client programs.
REQUIRED EXPERIENCE:
• HPLC/UPLC experience in quality/analytical/pharmaceutical industry or similar experience.
• Experience with multitude of HPLC/UPLC assays is a plus (SEC, CEX, Glycans, Peptide Map, etc.)
• Prior use of EMPOWER is preferred.
• Knowledge of GMP regulations in cGMP manufacturing environment.
• Working knowledge of scientific principles for wide range of analytical techniques strongly preferred.
• Strong knowledge and understanding of chemistry and chromatographic analytical instrumental technologies.
• Good knowledge of quality and regulatory requirements in the pharmaceutical industry.
• Good problem-solving skills and ability to multi-task
• Strong interpersonal and communications skills, written and oral.
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Ability to write, revise or review procedures, protocols or test methods.
• Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
• Ability to drive functional, technical and operational excellence.
EDUCATION:
Accredited Bachelor’s degree, preferably in Chemistry, Biochemistry or Biology.
WORK HOURS:
Full-Time; Mon-Fri 8am-5pm.
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