Expert I, QC

About the job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi has added two new Modulus Facilities to our global industrial footprint. These production units represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Modulus Facility will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimizing our impact on the environment. Our Modulus Facilities will help improve people's lives by giving them faster access to more treatments. In this context, we are looking for one Quality Control Expert (Microbiology) to participate in the setting up of the new QC laboratory for our new site based in Singapore.

Main Responsibilities

• Responsible for microbiological method validation/verification in the QC laboratory, to ensure robust test methods are implemented on time to support product and raw material testing in meeting manufacturing & supply deliverables. The microbiological methods include (but are not limited to) Bioburden, Endotoxin, and Sterility Test.
• Work closely with cross-functional teams to ensure timely completion of the applicable gap assessment, method validation/verification plan, method validation/verification protocol, and technical report. Ensure adherence to project timelines and critical milestones are met during New Product Introduction (NPI) initiatives.
• Perform trend review/investigation and data evaluation on method performance, recommending method improvements where appropriate.
• Lead QC laboratory investigation (including design of investigational testing strategy) to support root cause determination in microbial-related events.
• Provide technical leadership and guidance for the successful completion of major laboratory projects.
• Represent QC as technical contact/subject matter expert on topics in relation to microbiological test methods.
• Involvement in troubleshooting (such as when encountering enhancement and inhibition) and investigations/deviations which may require in-depth analysis of test methods.
• Participate in Change Control Request facilitation and management in relation to QC microbiological test methods.
• Perform compendial compliance assessment for the QC laboratory.
• Participate and contribute to laboratory continuous improvement.

About You

Education and experience

• Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Biology, or related Life Sciences or Technology with about 7-10 years of experience in microbiological method validation/verification in the pharmaceutical or biotechnology industry.

Key technical competencies and soft skills:

• Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies, and Data Integrity Requirements.
• Knowledge of the quality systems and associated technologies.
• Good understanding of good laboratory practices, good documentation practice, and data integrity requirements.
• Experience in microbiological method validation/verification.
• Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.
• Independent, disciplined, and assertive in decision-making and execution in laboratory start-up activities.
• Good communication skills to advocate QC positions with other functions, including during inspections.
• Continuous improvement mindset.
• Fluent in English speaking and writing.

Location: We are based at 5 Tuas South Street 2, Singapore 639328.