Head of Microbiology Lab

Position:
Head of Microbiology Lab, Biologics

Company:
Roche

Location:
China, Shanghai

Employment type:
Full time

Short Summary:
At Roche, you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally.

Responsibilities:
- Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line.
- Support EMPQ and establish risk-based environmental monitoring strategy and ensure its effective implementation.
- Responsible for the validation of microbiology methods, including supporting the confirmation of cleaning and disinfection processes, and the efficacy of disinfectants.
- Lead the setup of a microbiology laboratory that complies with regulatory requirements and build a BSL-II lab management system.
- Lead the execution and oversight of environmental monitoring and critical facility testing in accordance with Chinese GMP, EU GMP, U.S. cGMP regulations, and Roche/Genentech standards.
- Be accountable for audit readiness by ensuring compliance with effective standards and regulatory/statutory guidelines.
- Drive the continuous support of the effectiveness of the Contamination Control Strategy (CCS) and lead the organization of microbiology-related training.
- Be accountable for product release testing, ensuring timely delivery according to lead time requirements and guaranteeing compliance with Data Integrity (DI) standards.
- Lead the development of a competent team through coaching, mentoring, and training.

Requirement:
- Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above.
- 5 or more years of QC experience, with a focus on microbiology and aseptic processes.
- 3 or more years of People management experience.
- In-depth knowledge of quality control procedures and legal standards, with extensive experience in aseptic assurance and microbiological testing.
- Fluent communication skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.

Benefits:
- Roche is an Equal Opportunity Employer.