Associate manager/senior analyst-bioanalytical lab

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 GMP compliance with global GMP standards and China GMP requirement

• By assisting manager to conduct GMP self-inspection, and following-up the implementation action to maintain the global level of GMP compliance.
• By maintaining the quality system and documentation system to ensure quality system operation in QC meet the regulatory requirement.
• Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.
• By managing working schedule of relative section, to optimize utilization of human resources.
• By monitoring the timely calibration and maintenance of instrument within working section, to ensure they are functional well.
• By monitoring the timely entering and complementing of lab materials, including but not limit to reagent, solution, column/capillary and reference standard in working section, to ensure sufficient supply.

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.

Complete the assigned routine testing, issue the reliable analytical report in reasonable lead time.

• By mastering analytical methods within working section, complying with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.
• By rationalizing time allocation, optimizing combination the samples in hand to keep the reasonable lead time.
• By forming a good working habit to standardize experimental operations.
• By checking analysis result seriously and carefully to minimize mistakes and ensure accuracy and reliability of testing figures.

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.

Implement the analysis method validation

• By initiating the specified analysis method validation via planning, executing and reporting process.
• By organizing the resources to complete yearly method validation plan.

Implement the maintenance and calibration of the assigned instruments

• By accomplishing the calibration and maintenance of the assigned instruments, to ensure they are functional well to meet the analytical needs any time.
• By keeping the relevant document to trace the calibration & maintenance history and any change of the instruments.
• By keeping contact with instrument company to obtain the sufficient application technical support and repair service in time.

Qualification and Experience

• 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.

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 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.