Senior Scientist I, Bioanalysis and Translational Medicine

Job description

SUMMARY OF THE ROLE The Bioanalysis and Translational Medicine department centers on data‑driven bioanalysis and translational research, leveraging molecular/protein assays, cellular function and phenotyping, and biomarker with PK/PD platforms to support cell therapy programs including CAR‑T and mRNA‑LNP/lentiviral in vivo CAR. The Senior Scientist I is responsible for ensuring efficient, standardized, and compliant day-to-day laboratory operations. The role oversees and executes key operational processes including document management, sample and reagent lifecycle management, inventory control, staff training, and audit support. This position plays a critical role in maintaining laboratory compliance, data integrity, material traceability, and operational efficiency. ROLE & RESPONSIBILITIES Manage laboratory documentation by drafting, updating, reviewing, and training personnel on SOPs related to role-specific activities. Ensure compliance with SOPs and support consistent execution of laboratory processes. Receive, verify, register, and store biological samples, reagents, reference standards, and test articles in accordance with approved procedures. Manage material distribution and disposal in a compliant and traceable manner. Maintain complete and accurate records to ensure traceability, integrity, and compliance for all managed materials. Perform inventory checks and reconciliations, investigate discrepancies, and support corrective actions. Monitor stock condition and usability, including removal of expired, damaged, or obsolete items. Train and qualify new staff on relevant procedures and operational requirements. Support audits and inspections by preparing documentation and responding to queries related to the role. Contribute to continuous improvement of laboratory operational processes and compliance practices. REQUIREMENTS Essential: Bachelor’s degree or above in Biological Sciences, Chemistry, Pharmacy, Medical Laboratory Science, Life Sciences, or a related discipline. Minimum 5 years of experience in a biological R&D laboratory or a comparable laboratory environment. Proven understanding of routine laboratory operations, documentation practices, and compliance requirements. Experience in sample management, reagent management, inventory management, or related laboratory operational activities. Experience in drafting, revising, implementing, and training on SOPs. Ability to maintain accurate and complete records with strong attention to traceability and data integrity. Strong organizational skills and the ability to manage multiple operational priorities. Skills & Capabilities Strong knowledge of laboratory operational processes and controlled documentation systems. High level of attention to detail, accuracy, and compliance awareness. Effective communication and training delivery skills. Ability to identify operational issues, investigate root causes, and support implementation of corrective actions. Strong record-keeping and inventory control capability. Ability to work collaboratively in a cross-functional laboratory environment. Confidence in interacting with auditors, inspectors, and internal stakeholders. Desirable: Experience working in GMP and/or GLP laboratory environments. Experience supporting regulatory inspections, client audits, or other external audits. Familiarity with electronic inventory systems, laboratory databases, or document management systems. Previous experience in training and onboarding laboratory staff. Experience in process improvement or operational excellence initiatives within a laboratory setting. Date Posted 16-7月-2026 Closing Date 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.