Associate Manager - Bioanalytical

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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 etc. in 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 

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.