mRNA CoE - Quality Control Senior Analyst - Vaccines

Job Title: mRNA CoE - Quality Control Senior Analyst - Vaccines

Location: Waltham, MA

About the Job

As a Senior Quality Control Analyst in Analytical Sciences, you will work within the laboratory in support of Quality Control Method Life Cycle and routine testing activities. You'll also be responsible for writing and updating SOPs, data review, release testing and supporting other key lab activities.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory.

• Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, Capillary Electrophoresis (CGE), SoloVPE, and/or gel electrophoresis.

• Executes routine procedures based on bioassay methodologies, such as plate based assays (ELISA, qPCR, ddPCR, Ribogreen), gel electrophoresis, western blot and cell based assays.

• Support the laboratory start-up activities, participate in validation activities.

• Participate in continuous improvement of laboratory safety and quality compliance.

• Executes troubleshooting with guidance of supervisor or senior team members.

• Supports lab investigations as needed.

About You

• Earned Bachelor's, Master's or PhD in analytical chemistry, biochemistry, biotechnology or other relevant degree

• Bachelor's degree 5+ years (6 preferred), Master's degree 2+ years, or PhD up to 2 years of professional experience in the vaccine or pharmaceutical industry in the field of Quality Control analytics or Research and Development.

• 5+ years of experience in cGMP lab required.

• Practical experience or knowledge in biochemical and bioassay techniques (for example: UPLC/HPLC coupled with UV detection, CAD, DEDL, MS; Capillary electrophoresis; SDS-PAGE, SoloVPE, Spectramax plate reader, ELISA, qPCR, ddPCR, and others).

• Preferred knowledge of software (for example: LIMs, Empower, Chromeleon, Bio-Rad Image Lab)

• Must adhere to Good Documentation Practices (GDP)

• Sensitivity to Quality and health, safety and environmental (HSE) processes.

• Demonstrated ability to work independently as well as part of a team to complete assignments within defined time constraints.

• Essential qualities include ability to work in a fast paced, matrix environment; agility to respond to urgent requests.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex,