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.
Date Posted
04-1月-2026
Closing Date
30-5月-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.