Core Responsibilities section, keeping a professional tone suitable for job postings or regulatory documents:

Core Responsibilities

Research Design and Execution • Optimize experimental workflows to ensure compliance with GLP (Good Laboratory Practice) and ISO standards.
• Lead or participate in the design of preclinical study protocols for drugs/medical devices, including in vitroexperiments (cell culture, molecular biology assays) and in vivostudies (animal model development, pharmacodynamic/toxicological evaluation).
Regulatory Compliance Management • Maintain laboratory accreditation and certifications (e.g., SPCA animal use license, CNAS accreditation).
• Possess thorough knowledge of domestic and international clinical trial regulations (e.g., FDA 21 CFR, ICH guidelines, NMPA requirements in China); conduct compliance reviews of experimental protocols and prepare registration documentation.
Data Collection and Analysis • Utilize specialized software (e.g., GraphPad, SPSS, LabArchives) for data management to ensure traceability and integrity.
• Accurately record experimental data and perform statistical analysis using appropriate tools; prepare raw data reports and conclusive research summaries.
Animal Experiment Management • Monitor animal health status, manage unexpected occurrences during experiments, and minimize non-experimental variables.
• Plan and execute animal studies (mice, rats, dogs, etc.), including model establishment, dosing regimen design, sample collection, and histopathological analysis.
Cross-Department Collaboration • Provide regular updates to management on research progress and risk factors, and propose improvement measures.
• Work closely with pharmacology, toxicology, and formulation teams to advance project timelines; contribute to preparation of investigational new drug (IND) and new drug application (NDA) dossiers.
Literature Research and Knowledge Updates • Participate in international academic conferences to enhance technical expertise and industry influence.
• Keep abreast of cutting‑edge developments in the field through literature review to support innovative experimental directions.
Safety Management and Ethical Review • Lead or coordinate completion of ethical review for animal experiments (IACUC approval).
• Strictly adhere to laboratory safety operating procedures (SOPs) and properly handle hazardous chemicals and biohazardous waste.

TAIKANGNUO BIOTECHNOLOGY LIMITED

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