Experience Inc. Jobs

Job title: Expert I, QC

• Location: Singapore

• Hiring Manager: Senior Manager, Quality Control

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 Evolutive Facilities to our global industrial footprint. These production units (EVF) 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 Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.

Main Responsibilities

• Responsible for analytical method transfer and method validation in the QC laboratory, to ensure robust test methods are implemented on time to support product testing in meeting manufacturing & supply deliverables. The analytical methods include (but not limited to) UPLC, HPLC, GC, Electrophoresis, ELISA and spectrophotometry.

• Work closely with Analytical Science for method transfer/ validation strategy alignment, timely completion of the applicable gap assessment, method transfer plan, method validation protocol and technical report.

• Work closely with the Tech Transfer Manager to ensure adherence to project timelines and critical milestones are met during New Product Introduction (NPI) initiatives.

• Primary QC representative to provide QC tech transfer updates, highlights and challenges to cross-functional team members during Tech Transfer Tier meetings.

• Implementation of product stability program for the site.

• Partner with Quality Stability and Statistics team to ensure timely completion and approval of the stability protocols and reports.

• Overall responsible for the Analytical Life Cycle Management for the QC laboratory.

• Perform method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate.

• Provide technical leadership and guidance for the successful completion of major laboratory projects.

• Represent QC as technical contact/ subject matter expert on diverse topics in relation to analytical test methods.

• Involvement in troubleshooting and investigations/ deviations which may require in-depth analysis of test methods.

• Participate in Change Control Request facilitation and management in relation to QC test methods.

• Responsible for annual method review in the framework of annual product review.

• Responsible for the invalid assay trending program in the QC laboratory.

• Oversight role to compendial compliance assessment for the QC laboratory.

About You

Education and experience

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 7-10 years of experience in analytical method validation and method transfer 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.

• Experienced in analytical method validation/ method transfer.

• Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.

• Independent, discipline and assertiveness in decision-making and execution in laboratory start-up activities.

• Good communication skills to advocate QC positions with other functions, including during inspections.

• Keen to learn new technologies.

• Continuous improvement mindset.

• Fluent in English speaking and writing.

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)