Scientist - Analytical Development GMU
Waltham, Massachusetts, Framingham, Massachusetts
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Do you have what it takes for a successful career with Sanofi?
- Team player
Culture: Play to Win
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Position Overview/Department Description
Sanofi is seeking a highly motivated 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.
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 and review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to regulatory requirements
PhD in Biological Sciences (Cell Biology, Biochemistry, Molecular Biology or related field) or with a minimum of 0 - 2 years of relevant industry experience, or Master’s Degree in a relevant discipline and at least 4 years of relevant experience, or Bachelor’s Degree in relevant discipline and at least 6 years of relevant experience
Experience in developing and analyzing quantitative analytical methods
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
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.