In vivo scientist

TAIKANGNUO BIOTECHNOLOGY LIMITED; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Job summary

TAIKANGNUO BIOTECHNOLOGY LIMITED in Hong Kong is seeking a skilled researcher to design and execute GLP/ISO-compliant experiments, lead preclinical study planning, and ensure regulatory compliance across programs. You will collaborate with pharmacology and toxicology teams to advance IND/NDA initiatives and maintain accreditation standards.

The role emphasizes data integrity, ethical animal research oversight, and staying current with global guidelines and literature to drive project timelines.

Qualifications

• Experience with GLP/ISO standards and regulatory frameworks.
• Ability to design and interpret preclinical studies for drugs and devices.
• Proficient data collection, analysis, and documentation practices.
• Familiarity with laboratory accreditation and compliance processes.

Responsibilities

• Design and execute GLP/ISO-compliant research programs.
• Lead preclinical study protocol design for drugs/medical devices.
• Maintain accreditation and ensure regulatory compliance.
• Review trials per FDA/ICH/NMPA guidelines and prepare registrations.
• Collect and analyze data with GraphPad, SPSS, and LabArchives.
• Record data and produce raw reports and summaries.
• Oversee animal study planning and welfare.
• Coordinate cross-department updates and risk mitigation.
• Collaborate with pharmacology and toxicology teams on IND/NDA dossiers.
• Stay updated on scientific literature and ethical review processes.

Skills

GLP compliance

Regulatory knowledge

Data analysis

Animal handling

Cross-functional collaboration

Tools

GraphPad

SPSS

LabArchives

Job description

Here’s a polished English translation of your 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.