Head of Microbiology Lab, Biologics

About the role

Roche is looking for a Head of Microbiology Lab for its biologics business in Shanghai. The role leads the microbiology laboratory and covers contamination control, environmental monitoring, method validation, lab setup and product release testing, in line with Chinese GMP, EU GMP, U.S. cGMP and Roche/Genentech standards.

Key responsibilities

• Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line and drive its ongoing effectiveness.
• Support environmental monitoring (EMPQ) and set up a risk-based environmental monitoring strategy and its implementation.
• Validate microbiology methods, including confirming cleaning and disinfection processes and the efficacy of disinfectants.
• Lead the setup of a microbiology laboratory meeting regulatory requirements and build a BSL-II lab management system.
• Support performance qualification (PQ) of laboratory equipment and ensure routine operation.
• Lead compliance leadership, methodology management, audit readiness and product release testing, ensuring data integrity.
• Organize microbiology-related training and develop a competent team through coaching, mentoring and a skills competency development and appraisal program.

Required profile

• Bachelor's degree (Life Sciences, Microbiology or Analytical Sciences preferred).
• 5+ years of QC experience focused on microbiology and aseptic processes; MNC biopharma experience preferred.
• 3+ years of people management experience.
• Hands-on experience with CCS and EM control strategies, and with QC facility startup readiness and ramp-up.
• Experience with compliance inspections by NMPA, FDA, EMA, TGA or PMDA.
• Fluent English communication skills.

Required skills

• In-depth knowledge of quality control procedures and legal standards, and of aseptic assurance and microbiological testing.
• Advanced knowledge of industry regulatory requirements.
• Strategic thinking, agile ways of working and strong leadership and communication skills.