Expert I, QC

Job Title: Expert I, QC

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 minimizing our impact on the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.

Main Responsibilities:

1. 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 are not limited to) UPLC, HPLC, GC, Electrophoresis, ELISA, and spectrophotometry.
2. 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.
3. Work closely with the Tech Transfer Manager to ensure adherence to project timelines and critical milestones are met during New Product Introduction (NPI) initiatives.
4. Primary QC representative to provide QC tech transfer updates, highlights, and challenges to cross-functional team members during Tech Transfer Tier meetings.
5. Implementation of product stability program for the site.
6. Partner with Quality Stability and Statistics team to ensure timely completion and approval of the stability protocols and reports.
7. Overall responsible for the Analytical Life Cycle Management for the QC laboratory.
8. Perform method control trend review/investigation and data evaluation on method performance, recommend method improvements where appropriate.
9. Provide technical leadership and guidance for the successful completion of major laboratory projects.
10. Represent QC as technical contact/subject matter expert on diverse topics in relation to analytical test methods.
11. Involvement in troubleshooting and investigations/deviations which may require in-depth analysis of test methods.
12. Participate in Change Control Request facilitation and management in relation to QC test methods.
13. Responsible for annual method review in the framework of annual product review.
14. Responsible for the invalid assay trending program in the QC laboratory.
15. 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:

1. Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies, and Data Integrity Requirements.
2. Knowledge of the quality systems and associated technologies.
3. Good understanding of good laboratory practices, good documentation practice, and data integrity requirements.
4. Experienced in analytical method validation/method transfer.
5. Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.
6. Independent, disciplined, and assertive in decision-making and execution in laboratory start-up activities.
7. Good communication skills to advocate QC positions with other functions, including during inspections.
8. Keen to learn new technologies.
9. Fluent in English speaking and writing.

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.