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職位
1. Lab Establishment and Setup:
Lead the setup and validation of the new QC laboratory:

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Define the scope and requirements for lab infrastructure and layout.
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Select appropriate lab equipment and instruments, ensuring they meet the necessary technical specifications and compliance standards.
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Arrange the installation and qualification of lab equipment including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification).

Oversee laboratory layout design:

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Develop an efficient and compliant lab layout that adheres to GMP requirements and supports optimized workflow.
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Ensure that lab workstations, storage areas, and other lab spaces are designed to prevent cross-contamination and ensure safety.

Develop and implement standard operating procedures (SOPs):

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Create and document SOPs covering all aspects of lab operations, including equipment use, maintenance, safety protocols, and testing procedures.
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Ensure that SOPs are regularly reviewed and updated in line with regulatory changes and best practices.

2. GMP System Development:
Establish and maintain a robust GMP system:

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Develop and implement a comprehensive GMP framework that includes all aspects of lab management and operations.
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Ensure that QC processes align with GMP requirements to guarantee product quality and safety.

Develop and implement quality control procedures and protocols:

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Design and document detailed QC procedures for sample testing, handling, and storage.
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Implement protocols for method validation, calibration, and testing consistency.

Ensure proper documentation practices:

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Maintain accurate and complete records of all lab activities, including test results, equipment logs, and compliance documentation.
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Establish data integrity practices to ensure that all records are reliable and traceable.

3. Regulatory Compliance and Quality Assurance:
Ensure compliance with regulatory requirements:

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Ensure all lab operations comply with relevant regulatory standards (e.g., FDA, EMA, and other international guidelines).
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Stay updated on changes in regulations and industry standards to ensure ongoing compliance.

Coordinate and support for audits and inspections:

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Prepare the lab for internal and external audits and inspections by regulatory bodies.
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Collaborate with the quality department to manage audit findings and implement corrective actions.

Investigate and resolve quality-related issues:

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Perform root cause analysis for any deviations, out-of-specification results, or laboratory incidents.
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Develop and implement corrective and preventive actions (CAPAs) to address and prevent quality issues.

4. Collaboration and Communication:
Collaborate with cross-functional teams:

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Work closely with RA, Manufacturing, engineering and QA teams to support the transfer and commercialization of biological drug products.
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Provide QC expertise to support product development, process optimization, and troubleshooting.
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Communicate effectively with stakeholders
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Provide regular updates to internal and external stakeholders on lab activities, project progress, and compliance status.
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Foster strong relationships with external partners and regulatory authorities to facilitate cooperation and compliance.

5. Other business activities：
Understand and support day-to-day operations of the QC lab:

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Regularly review lab performance metrics and KPIs to identify areas for improvement.
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Implement continuous improvement initiatives to enhance lab processes and productivity.
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Leadership and project management
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Promote members to complete tasks according to project goals
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Have project node awareness and risk awareness, and actively communicate with project-related personnel, such as project stakeholders and project members.
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As the project manager, manage project conflicts, manage risks, and drive project implementation.

Education/Qualifications

● Bachelor of Science Degree or above
● Pharmacy, Chemistry, Biochemistry and equivalent
● Master at analytical science of Biological Product;
● At least 4 years’ experience in analytical testing and method validation of biologics
● At least 2 years’ experience of project management.

Leadership Competencies

● Models Integrity
● Focus on value and customer
● Align for success
● Deliver results
● Learn for the future

Job Required Competencies

● Project management skills
● Leading team capability
● Language skills – English