QC Senior Analyst (QC Analytical)

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 QC Senior Analyst (QC Analytical) 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:

Laboratory Setup & Project Execution

• Support the execution phase of the QC laboratory project by delivering assigned milestones and operational activities.

• Participate in laboratory start-up activities, including commissioning, qualification (C&Q), and validation oversight.

• Review and approve vendor-supplied documentation to ensure compliance with specifications and regulatory requirements.

Documentation & Compliance

• Author and review critical QC documentation such as URS, plans, protocols, reports, SOPs, and risk assessments.

• Ensure adherence to GMP, regulatory guidelines, and internal quality standards.

Analytical Testing & Method Transfer

• Perform QC testing (analytical, biochemistry, and/or physico-chemical) for water, raw materials, and product samples.

• Lead or support method transfer, validation, and verification activities to ensure robust analytical performance.

Training & Continuous Improvement

• Train and mentor new team members on QC laboratory operations and testing procedures.

• Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and performance metrics (e.g., deviation/OOS rate, sample turnaround time).

Education and experience

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 5-8 years of experience in QC lab operations and testing. Experience in 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, 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 the 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.