Senior Scientist

Job Title: Senior Scientist

Location: Waltham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Sanofi is seeking a highly motivated Senior Scientist to join the Analytical Development team in our growing Genomic Medicines Unit (GMU) in Waltham, MA. The candidate will play a critical role in the design and development of cell and molecular assays to support product characterization studies, process development, and preclinical and clinical lot release and stability testing of viral (AAV) and non-viral gene therapeutics, including LNP/mRNA/DNA modalities. A successful candidate will have a strong scientific background in developing analytical methods, excellent oral and written communication skills, and a team player approach to problem-solving.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Define scientific approaches and analysis methods for quantitative bioassays, immunoassays, and molecular assays including qPCR and digital PCR

• Evaluate and implement new technologies within the GMU Analytical Development Team, with an emphasis on state-of-the-art analytical assays for gene therapy products

• Participate in the development, qualification, and validation of analytical methods

• Ensure timely completion and delivery of analytical results with GMP documentation to support product development during clinical phases

• Write analytical sections of IND/IMPD filings

• Write and review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to regulatory requirements

About You

Basic Qualifications:

• PhD in Biological Sciences (Cell Biology, Biochemistry, Molecular Biology or related field), or Masters Degree in a relevant discipline and at least 4 years of relevant experience,

• or Bachelors Degree in relevant discipline and at least 6 years of relevant experience

• Experience in developing and analyzing quantitative analytical methods

Preferred Qualifications:

• Understanding of MOA for gene therapy-based therapeutics

• Experience with quantitative PCR including primer design, digital PCR, ELISA, cell-based relative potency assays

• Familiarity with software packages to analyze dose-responses and statistical analysis (SoftMax, JMP, GraphPad Prism etc)

• Familiarity with QbD principles and DOE approaches for method development and optimization.

• Working experience in GMP environment will be considered an advantage

• Experience with validation and transfer of analytical methods according to ICH guidelines

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 its 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, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Better is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets 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 !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .