Sanofi Group Scientist Gene Therapy Process Analytical Development in Waltham, Massachusetts
The Genomic Medicine Unit (GMU) operates with the mission to develop robust, scalable, cost effective, and innovative cell and viral vector manufacturing processes and platforms. The BioProcess Analytics (BPA) group is responsible for developing and executing a range molecular, biochemical and immunological methods to support our R&D team in process development for current and future cell and gene therapy manufacturing platforms.
The BioProcess Analytics group located in Waltham, MA, is seeking an experienced analytical Scientist to join our team of talented individuals.
The successful candidate must have proven capabilities to independently manage multiple projects and solve challenging problems. Relevant experience in developing molecular and cell-based analytical method, with a focus on cell and gene therapy analytics, is preferred. The candidate must be self-driven, independent, collaborative, and able to communicate effectively and work in a fast-paced environment.
Independently perform experiments related to AAV and other non-viral gene therapy platforms to support the development of a wide array of molecular and bioassays like qPCR, ddPCR, ELISA, cell-based viral vector methods like potency and virus infectivity (TCID50) assays.
Design, plan and execute method development experiments and perform deep data dives.
Troubleshoot experiments, OOS results and, communicate findings to appropriate groups.
Manage individual assay development plans that includes development of study design, execution, method optimization and verification of analytical methods within defined timelines.
Evaluate new technologies to complement and enhance current analytical capabilities, with a focus on automation and high throughput capabilities.
Work closely with other groups within the organization to identify gaps in analytics and provide meaningful solutions for enhanced process understanding and life cycle management
Be able to develop best practices and drive for results in a matrix organization.
Write and review protocols, SOPs and technical reports.
Represent group and present data at internal and external meeting and conferences.
Mentor, train and support junior staff and build a culture of support and collaboration.
Self-driven, motivated, proactive team player with excellent organizational skills.
PhD in biological sciences or, a Master’s degree with a minimum of 4 years of relevant industry experience or a Bachelor’s degree with a minimum of 8 years of relevant industry experience.
Demonstrated knowledge and experience in cell-based assays, qPCR and ddPCR techniques
Demonstrated ability for critical thinking, problem solving and innovation
Demonstrated ability to multi-task, prioritize and possess strong time-management skills
Demonstrate great attention to detail and good record-keeping.
Have good work ethics and be able to work on multiple projects in a fast-paced environment.
Experience in developing and implementing novel methods on qPCR and ddPCR platforms
Experience using statistical tools e.g. DOE to develop analytical methods.
Experience working with automated analytical technology platforms for high throughput testing.
Experience working with viral vectors, AAV, cell and gene therapy manufacturing platforms.
Experience with gene therapy regulatory guidance’s, specific to cell and gene therapy products.
Special Working Conditions:
Required to work in a Biosafety Level 2 environment (BSL2).
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
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.