Responsibilities:
61 Promptly and properly document tests and results per Good Documentation Practice (GDP) requirement.
61 Perform GMP record review for physicochemical routine testing of Antibody-Drug Conjugate (ADC) samples according to relevant Standard Operation Procedure (SOP), Analytical Method Procedure (AMP), protocols, test methods and cGMP requirements.
61 Write and revise AMP, method transfer/qualification/validation protocol and report.
61 Write SOP and other technical documents
61 Perform laboratory investigation following relevant SOP.
61 Perform method optimization and troubleshooting when necessary and lead technical discussion.
61 Proactively search for opportunities to improve efficiency, quality and achieve technical excellence.
61 Perform deviation investigation, change control, and CAPA following relevant SOP.
61 Work as QC Function Leader to coordinate project related activities in QC
Requirements:
61 Education background in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or others related field.
61 At least two year experience in (bio)pharmaceutical industry for Degree of Master or Degree of Bachelor.
61 Chromatographic and spectral techniques related to HPLC, UPLC, GC, CE, icIEF, IR and Raman, etc.;
61 Compendial testing such as pH, osmolality, conductivity, etc.
61 Knowledge in FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines
61 Critical thinking, scientific reasoning and problem solving skills
61 Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc