Associate Manager / Senior Analyst - Bioanalytical Lab

About the role

Roche is hiring an Associate Manager / Senior Analyst for its bioanalytical laboratory in Shanghai. The role covers GMP compliance, quality assurance, daily analytical testing, project management and instrument maintenance, with a focus on biologics.

Key responsibilities

• Support the manager in GMP self-inspections and follow up corrective actions to maintain global GMP compliance, and keep the quality and documentation systems in line with regulatory requirements.
• Manage sample distribution and inspection processes so analytical reports are released on time, and manage work schedules to optimise resource use.
• Monitor instrument calibration and maintenance, and the replenishment of reagents, solutions, columns, capillaries and reference standards.
• Implement and transfer new bioanalytical technologies, communicate with external collaboration projects, write and optimise SOPs, and track research project progress and data.
• Complete routine testing, issue reliable reports within a reasonable lead time, and report abnormal results and unexpected findings to the supervisor immediately, taking part in investigations.
• Carry out analysis method validation, including planning, execution and reporting, and organise the annual validation plan.
• Maintain and calibrate assigned instruments, keep records of their history and changes, and liaise with instrument vendors for technical support and repairs.

Required profile

• Bachelor's degree or above in pharmacy, chemistry, biochemistry or an equivalent field.
• Proficiency in biological product analysis techniques.
• At least 4 years of experience in analytical testing and method validation of biologics.
• At least 2 years of project management experience.
• English and Chinese.

Required skills

• Project management skills
• Team leadership capability
• Knowledge of GMP and QC analytical methods