Associate Manager Bioanalytical Technology Laboratory

Shanghai - China

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job 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. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

1. Lab Establishment and Setup:

Lead the setup and validation of the new QC laboratory:

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

Oversee laboratory layout design:

Develop an efficient and compliant lab layout that adheres to GMP requirements and supports optimized workflow.
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):

Create and document SOPs covering all aspects of lab operations including equipment use maintenance safety protocols and testing procedures.
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:

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

Develop and implement quality control procedures and protocols:

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

Ensure proper documentation practices:

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

3. Regulatory Compliance and Quality Assurance:

Ensure compliance with regulatory requirements:

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

Coordinate and support for audits and inspections:

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

Investigate and resolve quality-related issues:

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

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

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

Regularly review lab performance metrics and KPIs to identify areas for improvement.
Implement continuous improvement initiatives to enhance lab processes and productivity.
Leadership and project management
Promote members to complete tasks according to project goals
Have project node awareness and risk awareness and actively communicate with project-related personnel such as project stakeholders and project members.
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 & Chinese

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience:

Manager