Senior Scientist I, Bioanalysis and Translational Medicine

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.

• 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.

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