Active Analysis Researcher
Job Responsibilities
1. Responsible for the development, optimization, validation, and transfer of analytical methods such as bioactivity methods (including ELISA, cell-based assays), biological residue, and safety analysis testing (including residual HCP, residual DNA, residual Protein A), as well as writing and revising related documents to support project progress.
2. Responsible for the evaluation and application of new technologies/instruments.
3. Formulate and execute monoclonal antibody characterization schemes for IND and BLA submissions, mainly providing support for formulation development through structural and degradation pathway characteristics and stability-related studies.
4. Possess cross-departmental communication skills to effectively follow up and communicate project progress.
5. Analyze and solve abnormalities encountered in experiments, and promptly organize and analyze data to support project progress.
6. Able to proactively undertake multiple responsibilities and possess good decision-making skills.
Job Requirements
1. Master's degree or equivalent and above in related fields such as cell biology, molecular biology, biochemistry, pharmacy, immunology, biotechnology, or basic medicine.
2. At least 3 years of relevant work experience; or a Ph.D. with more than 2 years of relevant work experience is preferred.
3. Candidates familiar with the optimization and construction of expression vectors, transfection, Western, ELISA, cell-based assays, cell proliferation inhibition, apoptosis, phagocytosis, ADCC, CDC, enzyme activity, flow cytometry, etc., are preferred. A background in statistics/mathematics is a plus.
4. Familiarity with cGMP, pharmacopoeia testing, biological drug application, and registration regulations is a plus.
5. Capable of literature retrieval, with excellent English skills, able to fluently read and translate English literature.
6. Strong curiosity and eagerness to learn new things.
7. Possess a good sense of dedication, teamwork spirit, and communication and coordination skills.
HR Email: hr@biotech-pack.com (If interested, please contact us via this email or directly submit your resume.)
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