Major responsibilities

• Proficient in qPCR, dPCR, and nucleic acid gel electrophoresis; perform planned testing of plasmid, lentiviral, and cellular samples, complete testing records, conduct result review, issue test reports, and promptly escalate to supervisors as required.
• Comply with molecular laboratory area requirements and contribute to establishing GMP‑compliant area management policies and workflows.
• Participate in drafting SOPs for molecular analytical methods applied to in‑process controls, intermediates, and finished products.
• Propose or participate in analytical method optimization, and support method transfer and validation, including protocol development, experimental execution, report drafting, and investigation of anomalies.
• Contribute to stability study protocol development for intermediates and finished products; participate in stability testing and perform stability data review.
• Participate in training of molecular testing technicians, including onboarding of new hires and refresher/continuing training (e.g., GMP regulations, technical knowledge, and molecular testing SOPs).
• Support product annual reviews.
• Identify suitable outsourced testing service providers based on business needs; participate in supplier audits, arrange sample submission, promptly collect outsourced test reports, and verify that results meet requirements.
• Manage instrument login account permissions and original data associated with molecular testing.
• Procure molecular testing reagents, consumables, and reference standards per plan to meet routine testing needs, and store/manage them per applicable procedures.
• Ensure proper operation and routine maintenance of molecular testing instruments and equipment; report malfunctions for timely repair.
• Support internal and external audits and complete remediation per plan and requirements.
• Complete other laboratory‑related tasks assigned by management on schedule.

Education, Qualifications, Skills and Experience

• A bachelor’s degree or higher in Chemistry, Biopharmaceutical Analysis, Molecular Biology, Cell Biology, Immunology, or a closely related discipline is required.
• At least three years of experience in pharmaceutical testing or pharmaceutical quality-related functions.
• Familiarity with molecular laboratory quality standards for pharmaceuticals and proficiency in molecular diagnostic techniques, including nucleic acid–based assays.
• Familiarity with the major laws and regulations of the NMPA.
• Strong organizational, communication, and teamwork capabilities, with well‑developed interpersonal skills to interact effectively across multiple teams.