Principal Scientist, Downstream, Purification, CMC
La Jolla, California
This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.
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.
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Principal Scientist, Downstream, Purification, CMC
Synthorx, a Sanofi Company, is using a novel synthetic biology platform for the discovery and production of improved protein therapeutics. We have advanced a revolutionary technology that expands the genetic alphabet to drive the site-specific incorporation of multiple non-natural amino acids into proteins of any size, and to manufacture these improved proteins at scale. This technology enables the design of biotherapeutics with useful chemical functionality and opens up opportunities to make novel protein therapeutics to previously difficult to drug targets. We are hiring a Principal Scientist Downstream Processing to join the Process Development CMC group. The successful candidate will have a strong background in protein biochemistry and purification of protein expression in E. coli.
• Design and develop robust, scalable and cost-effective purification process for microbial-derived biologic therapeutics using protein refolding, chromatography, normal and tangential flow filtration.
• Direct, design and execute full process characterization / validation (PC/PV) using strategy and statistical tools from QbD including risk analysis, DoE, identification of Critical process Parameters, and Controllability.
• Support Person in Plant (PIP) activities leading up to, during and post-GMP manufacturing.
• Perform data analysis on the performed and related activities, design hypothesis and test to improve process related to recovery or scalability, prepare technical reports, DoE’s and internal and external presentations.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
• Ensure effective, high-quality, timely and appropriate documentation in reports and laboratory notebooks.
• Effectively maintain good communication and collaborate with cross-functional colleagues for successful execution/completion of project.
• Support preparation of reagents, buffers, and equipment as needed to support experiments.
• Mentor junior staff and provide insight and technical expertise for project progression.
• Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry or equivalent related fields with 7 years relevant experience or Bachelor’s/Master’s degree with 12+ years relevant industry experience required.
• Strong hands-on experience in protein related purification techniques such as filtration, chromatography, UF/DF, AKTA, UNICORN, A280, ion exchange, size exclusion, reverse phase, and HPLC systems. Experience with different modes of chromatography is desirable.
• Knowledge and skills in biochemical characterization of proteins including analytical and biophysical techniques.
• Statistical knowledge, JMP software required.
• Supervisory, managing direct reports experience is a plus.
• Experience in cGMP, CMC activities, BLA submission is a plus.
• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills.
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.
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