百济神州
放行分析师 Release Analyst
岗位职责
- Responsible for routine biochemical testing activities, including product release testing for residual DNA, host cell protein (HCP), residual Protein A, residual IGF-I, and other biochemical assays.
- Responsible for method transfer and validation of biochemical assays, including preparation of validation protocols and reports for residual DNA, HCP, residual Protein A, and other related methods.
- Draft, review, and update laboratory procedures, work instructions (WIs), analytical methods, and records to ensure compliance with GMP and regulatory
任职要求
. - Complete OOS, OOT, and AE investigations related to biochemical assays in a timely manner. - Responsible for equipment qualification, routine maintenance, and cleaning to ensure equipment is maintained in a qualified state and operates properly. - Troubleshoot experimental issues independently and support or lead investigations of deviations and abnormal events. - Independently prepare validation protocols, validation reports, analytical procedures, and other technical documents. - Manage critical reagents used in the biochemical laboratory to ensure compliance and continuous availability. - Manage reference standards and support comparability studies as required. - Ensure compliance with company EHS policies and procedures, fulfill EHS-related responsibilities, and promptly report EHS incidents, hazards, and risks. Qualifications & Competencies - Bachelor's degree or above in Pharmacy, Biology, Chemistry, Biochemistry, Biotechnology, or a related discipline. - Good command of English and computer skills; CET-4 (College English Test Band 4) or above. - Positive, responsible, and willing to learn and take initiative. - Good teamwork, organizational, analytical, and problem-solving skills. - Good communication and interpersonal skills.
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