Associate Manager Bioanalytical

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

Implement the compliance of biological large molecule related specification in the product life cycle

Support the registration department in preparing for the launch of new biological large molecule products such as technical support for registration specification coordination of reagents and consumables etc.

Track CMC changes of biological large molecule products such as analytical methods specification standards and affected Chinese Registration Standards ( CRS )

Maintenance biological large molecule products gap and risk assessment (GRA ) system

Coordinate GRA drafting by bioanalysis lab on the new launch biological large molecule products and marketing products

Review and maintenance of biological large molecule products gap and risk assessment (GRA )

Communicate GRA related information regularly with PTR China AQA and convey the information to relevant personnel such as bioanalysis lab

Implement relevant work according to the release and changes of content related to Chinese Pharmacopoeia and biological large molecule products

Support QC s analytical science and technology team to ensure pharmacopoeia compliance comments feedback and implementation of biological large molecule products

Ensure Chinese Pharmacopoeia requirement implemented in the GRA of biological large molecule products

Coordinate bioanalysis lab to implement relevant actions based on GRA conclusions for products affected by the Chinese Pharmacopoeia

Project management and process management

Responsible for the implementation and transfer of new bioanalytical technologies

Responsible for communicating with external collaborative projects

Responsible for the SOP formulation opinion collection and optimization for QC research project process management

Responsible for tracking the progress and data summary of bioanalysis lab research projects

Implement the bioanalytical new technology projects.

Initiate assigned new technology projects by writing project plans such as digitalization projects and new system projects

Catalyze cross-function cooperation follow up on project actions and complete projects by organizing and coordinating resources. For example external cooperation projects

Manage work plans in related areas and optimize personnel efficiency

Monitor the project process and urge project members to complete project actions within a reasonable period

Support on HA lab including import testing and collaboration projects

Technical cooperation projects with HA lab such as method development validation and monograph drafting

Trouble shooting on import testing of biological large molecule products

Implement the promotion of bioanalytical technology in local laboratories develop a new technology roadmap and cultivate technical talents in the field of bioanalysis.

Implement the method transfer of Roche products identify the gaps between the receiving and donor sites and reduce transfer risks.

Discover new industry technologies and new analysis directions and promote and popularize them to relevant personnel and laboratories

Participate in communication with experts at the headquarters to obtain adequate and latest technical support.

Provide technical support and share knowledge and experience in the field of work.

Identify and develop biotechnology talents provide talent training programs and assist laboratory managers in completing the formulation of biotechnology training plans for personnel.

Implement GMP compliance with global GMP standards and China GMP requirement

Responsible for the local implementation of corresponding PQS files

Organize and coordinate the annual Biologics Analytical Technology Workshop

Responsible for the process of the annual Biologics Analytical Technology Workshop and ensuring the backend operations and orderly development of the workshop

Coordinate the resources of various teams and suppliers to ensure the layout translation catering and transportation of the workshop

Responsible for organizing relevant experts and laboratory personnel to proofread translate and bind materials for the workshop

Responsible for organizing the inventory after the workshop internal sharing meetings etc.

Report the abnormal status unexpected results to supervisor with initiative and in time.

By reporting abnormal status and unexpected results during analysis processing at first time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.

By involving the investigation process to provide actual data and information to help avoid the same issue occurring again.

Responsible for communicating and cooperating with project-related lab managers following up on project progress and organizing resources and promoting project implementation.

Communicate project-related information new and marketed product information and share experiences to bioanalysis lab members.

Abide by lab safety regulations to prevent occurrence of accident.

By obeying the safety instruction of the storage usage and disposal of reagent narcotics medicines lab waste.

By following the usage instruction of facilities of water electricity and steam lab.

Check relevant work areas to ensure laboratory safety

Have the ability to find and solve the problems occurred in routine work.

By finding and solving the problems in correct way and in time to ensure the normal operation of routine work.

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. Experience in cell culture and bioassay is preferred.

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.