Associate Manager - P/C Analytical Laboratory

About the role

Roche is hiring an Associate Manager for its Physical Chemistry (P/C) analytical laboratory in Shanghai. The role covers routine sample testing, instrument maintenance and calibration, method validation, quality review of analytical data and mentoring of analysts.

Key responsibilities

• Complete routine sample inspections and issue reliable analytical reports within a reasonable turnaround time.
• Master analytical methods in the working section, optimise sample combinations and keep accurate records to ensure data reliability.
• Maintain and calibrate assigned instruments, keep their maintenance and calibration history, and liaise with instrument vendors for technical support.
• Provide technical support to analysts and share knowledge and experience within the team.
• Guide subordinates through analysis method validation and carry out assigned validations according to the validation plan.
• Investigate results outside control limits and manage trend analysis in the P/C lab.
• Review and approve analytical data in the instrument and LIMS systems and on paper records.
• Solve problems in routine work promptly and accurately.

Required profile

• Bachelor's degree (chemistry or a related discipline preferred); graduate or higher degree preferred.
• 5+ years of work experience in the pharmaceutical industry or a related field.
• Prior experience in small-molecule method transfer, especially cross-border, is strongly preferred.

Required skills

• Expert knowledge of analytical laboratory operations supporting commercial manufacturing.
• Expert knowledge of cGMP and laboratory safety procedures.
• Expert knowledge of pharmaceutical quality system principles, practices and standards.
• Basic knowledge of pharmaceutical microbiology.
• Strong spoken and written English.