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 Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our facilities will help improve people’s lives by giving them faster access to more treatments.
In this context, we are seeking a highly motivated Quality Control Expert to join our team and play a key role in establishing and operating a state-of-the-art QC laboratory at our new Singapore site. This position offers an exciting opportunity to contribute to the successful start-up of a new facility and ensure compliance with global quality standards.
Main Responsibilities
Support the routine operations of the new QC laboratory based in Singapore:
Method Validation & Verification
Design, execute, and document method validation studies for raw material testing in accordance with regulatory requirements
Perform compendial method verification for USP, EP, JP, and other pharmacopeial methods to ensure suitability for intended use
Establish acceptance criteria, accuracy, precision, specificity, linearity, detection limits (LOD), and quantitation limits (LOQ)
Lead method transfer activities between manufacturing sites
Prepare and review validation protocols, reports, and technical documentation
Raw Material Testing & Release
Review and approve analytical data to support raw material release decisions
Investigate out-of-specification (OOS) and out-of-trend (OOT) results
Technical Expertise & Continuous Improvement
Serve as subject matter expert for analytical techniques including HPLC, GC, UV-Vis, titration, wet chemistry, and spectroscopy
Troubleshoot analytical method issues and implement corrective actions
Drive continuous improvement initiatives for testing efficiency and method robustness
Evaluate and implement new analytical technologies and methodologies
Quality & Compliance
Ensure all testing activities comply with cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)
Support internal and external audits, inspections, and regulatory submissions
Author and review SOPs, work instructions, and quality procedures
Participate in change control, deviation investigations, and CAPA processes
Collaboration & Leadership
Provide technical training and mentorship to QC analysts
Support new product introductions and process improvements
Education and experience
Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 10-12 years of experience in QC lab operations and testing
Experience in raw material method validation and method transfer in the pharmaceutical or biotechnology industry preferred.
Key technical competencies and soft skills:
Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
Hands-on experience with analytical techniques such as HPLC, GC, ICP-MS, UV-Vis, FTIR, Karl Fischer (KF), spectroscopy, and wet chemistry methods.
Strong understanding of method validation, transfer, and regulatory requirements (ICH, USP, EP).
Experience in regulatory audits will be advantageous.
Strong interpersonal relationships and good communication skills to establish partnerships with key stakeholders.
Excellent documentation skills and familiarity with electronic systems (LIMS, Empower).
Ability to work collaboratively in a fast-paced start-up environment.
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
