QC Senior Analyst (QC Analytical) at Sanofi Aventis US LLC

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

03 Apr, 26

Salary

0.0

Posted On

03 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Good Laboratory Practices, Good Documentation Practice, Data Integrity Requirements, Analytical Techniques, HPLC, GC, Spectroscopy, Wet Chemistry Methods, Method Validation, Method Transfer, Regulatory Requirements, Interpersonal Relationships, Communication Skills, Documentation Skills, Electronic Systems, Collaboration

Industry

Pharmaceutical Manufacturing

Description

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. 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 and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement 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 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

Responsibilities

Support the routine operations of the new QC laboratory, including laboratory setup, project execution, and compliance with global quality standards. Perform QC testing and lead method transfer and validation activities.