Senior Lab Operation Specialist
AstraZeneca is seeking a highly motivated scientist with a strong laboratory background in bioanalysis to join the Bioanalytical laboratory in Clinical Immunology and Bioanalysis (CIB) at AZ China headquarter in Zhangjiang, Shanghai. The laboratory mainly focuses on PK/ IMG/PD assessment of large-molecule drugs, and you will play an essential role in development of biological therapeutics through supporting clinical sample testing and data delivery.
The role requires strong understanding in bioanalytical lab operation, biorepository, quality control, instrument/equipment management, procurement, import/export logistics, and quality assurance and documentation. The desired candidate is expected to have a basic understanding of the principals related to the research and development of new drugs.
- Support other lab members for successful PK/IMG/PD immunoassay transfer, trouble shooting, validation, sample testing and data reporting.
- Collaborate with Procurement teams to purchase, import and inventory instrument/equipment, chemicals, biological reagents and human blood samples that are required for method validation and sample testing conducted by the lab.
- Purchase, stock and inventory lab and office consumables to ensure their sufficiency for the planned activities and achievement of project milestones.
- Manage high-throughput clinical specimen control function: tracking, receipt, inventory and reconciliation with emphasis on compliance and accuracy to ensure timely sample distribution and testing; Maintain and archive high-volume clinical specimen documents throughout specimen life cycle (receipt through destruction).
- Pursue resolutions to identified logistical concerns with couriers, central labs and clinical facilities to secure specimen quality and ensure timely shipping/receiving of clinical materials.
- Cooperate with external metrology service providers to perform routine calibration on laboratory equipment/instrument, including but not limited to pipette, balance, incubator, refrigerator and freezer, to meet GxP requirements throughout the lab.
- Coordinate services as scheduled for preventive maintenance and repairing of various equipment and system within the laboratory and for acquirement of necessary certification for fume hood, biosafety cabinet, plate reader and so like.
- Assist in ensuring environmental health and safety in the laboratory and recommend/implement practices to improve laboratory efficiency or safety.
- Provide front desk coverage for the laboratory to ensure that all the visitors are logged in, receive a visitor badge and are escorted to their contact(s) within the facility, and that all couriers are managed appropriately and their accessibility is limited.
- Fulfill QA documentation functions, including but not limited to issuance of controlled documents (e.g. forms, notebooks and protocol/study numbers), maintenance of document tracking system, storage of hard copy documents, management of document archiving system, scanning completed documents (e.g. notebooks and study binders), and coordination of delivery and retrieval of archived documents between the lab and the external storage facility.
- B.Sc. or M.Sc. Degree in Biology, Biochemistry, pharmacology or related field with 5+ (B.Sc.) or 2+ (M.Sc.) years of pharma/Biotech industry experience.
- Acquaintance with lab operation, procurement, customs clearance, clinical sample management, quality control, and quality assurance documentation is a plus.
- Working experience in a GxP-regulated environment is preferred.
- Attention to details and strong organization/teamwork skills.
- Ability to overcome challenges, develop and implement effective strategies, and quickly adapt to new responsibilities.
- Excellent communication skills in an inter-disciplinary environment and capable of managing multiple tasks.
- Proficient in both Chinese and English (both oral and written).
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 authorisation and employment eligibility verification requirements.