Company Overview:

WuXi Chemistry, a business division of WuXi AppTec, provides contract services for new drug development from discovery to commercial. Our unique CRDMO model offers an integrated solution combining traditional CRO (contract research organization), CDMO (contract development and manufacturing organization) and CMO (contract manufacturing organization) services under one roof.

As a world leading chemistry service organization, WuXi Chemistry have over 22,000+ employees from our 16 research, development or manufacturing sites worldwide, serving over 2,400+ clients from top pharma to virtual biotech companies. Our services cover all categories for all synthetic molecular modalities, meeting any material requirement at any scale.

Report to: QC Head

Responsibilities:

1. Responsible for the daily operation and management of the microbiology lab, ensuring smooth progress of test projects and public system monitoring.
2. Responsible for the development, verification, validation, transfer, and method effectiveness of microbial and endotoxin analysis methods.
3. Organize lab events, deviations, and OOX investigations occurring during GMP testing and method verification/validation/transfer.
4. Initiate and review all change controls related to microbiological testing (including validation, methods, and microbiological-related annual qualification), and track timely execution of CAPA.
5. Responsible for building the capability of the microbiology team, developing new business capabilities (such as oligonucleotide & peptide), and cultivate a talent echelon.
6. Responsible for the paperless construction and maintenance of microbiology lab, such as ELN, LIMS, etc.
7. Ensure personnel are qualified through training and maintain continuous training and assessment.
8. Organize timely data review by personnel to ensure related deviation investigations are completed before product release.
9. Maintain good communication with same business laboratories of other sites, ensuring consistency in documentation systems and execution processes.
10. Participate in the maintenance and optimization of processes to ensure personnel are following the procedures.
11. Participate in customer audits and government inspections, promptly complete rectifications of findings, and ensure GMP compliance.
12. Timely track work progress, strengthen communication with internal and external customers, and establish stable and good relationships.
13. Ensure laboratory safety and personnel safety.
14. Responsible for other tasks temporarily assigned.
15. Assist department leaders in building a high-efficiency team.
16. Enhance the team's capabilities for new business to meet new business requirement.
17. Bring out the initiative, enthusiasm, and creativity in each team member.
18. Energize the entire team.

Requirements:

1. Education: Pharmacy or microbiology related major, bachelor's degree or above.
2. Major: Understand pharmaceutical production, microbiology, testing, and quality management; familiar with GMP regulations.
3. Language: Proficient in English, fluent in spoken and written English.
4. Misc: Good computer skills.
5. Experience: Over 5 years of work experience, with more than 3 years in managing a GMP microbiology team.
6. Capability:

• Good coordination and communication skills.
• Ability to determine problems, gather information, understand facts, and draw correct and effective conclusions through scientific reasoning.
• Project management and tracking skills.
• Ability to manage budgets and assets, controlling lab expenses
• Guide and supervise the work of subordinates.
• Responsible for assigning work, assessing, and motivating subordinate employees.