Position Overview/Department Description
The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support.
The GMU CMC organization is seeking a Scientist to join our Cell Therapy Process Development (CTPD) team that is highly focused on the rapid development of novel cell therapeutics. The successful candidate must have deep scientific knowledge and hands on experience in cell therapy process and product development and GMP manufacturing. The candidate must be highly motivated, independent, collaborative, and able to communicate effectively within a cross-functional team environment. The Scientist role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies to build robust and efficient production processes consistent with patient safety standards. Key Responsibilities:
- Independently develop, design, and conduct cell therapy process development experiments and evaluate new technologies to increase product yield and process understanding using design of experiment
- Develop, maintain, and demonstrate advanced knowledge of principals and techniques in cell culture, molecular biology, and cell biology
- Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish findings as well as speak both internally and externally as industry leaders
- Lead development of study design, optimization of process conditions, and perform troubleshooting experiments and communicate findings with appropriate working groups
- Perform data analyses, write protocols, author development technical reports, contribute to regulatory findings, and provide internal and external presentations
- Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
- Ability to work in Biosafety Level 2 environment, follow safe lab procedures, and maintain good laboratory practice (GLP)
- Willingness to work with human blood products
- Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency
- Mentor and support junior staff and build a culture of support and collaboration
- Perform extended hours, weekend, and holiday work to support ongoing lab activities
- Occasional travel
- PhD in biological sciences or related discipline or Master's degree with a minimum of 4 years of relevant experience or a Bachelor's degree with a minimum of 6 years of relevant experience
- Extensive experience in primary cell culture and aseptic technique
- Experience with immune cells, preferably NK cells, including culture, expansion, transfection, formulation, and experience with common immunological assays such as flow cytometry and ELISA
- Experience with molecular biology techniques such as DNA/RNA isolation, PCR, and RT-PCR
- Experience with gene editing technologies, such as CRISPR/TALEN/ZFN, and Next Generation Sequencing
- Experience in CMC and drug development cycle
- Experience with process technology transfers and performing gap analyses and risk assessments
- Expertise in technical report writing, and ability to draft manuscripts for external publications
- Excellent oral and written communication skills
- Excellent organizational and record keeping skills
- Experience writing CMC components of regulatory dossiers
- Knowledge of GMP manufacturing, process development/validation, and scale-up manufacturing
- Knowledge of product comparability, target product profile, and quality risk assessment activities
- Innovative, critical, and creative thinker
- Experience in mentoring junior staff
- Ability to build and nurture cross-functional relationships
- Ability to communicate and represent group in diverse, multi-functional meetings
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.