Principal Scientist – LCM Technical Lead
| Company | Sanofi |
|---|---|
| Location | Framingham, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Degree in chemical engineering, biotechnology, biological sciences, or other relevant discipline
- BS with 10+ years of professional experience or MS with 7+ years of professional experience or PhD with 5+ years of professional experience
- Minimum of 5 years of hands-on experience in process development in either upstream or downstream, writing of sections in regulatory briefing packages or dossier and associated discussions with agencies
- Minimum of 4 years’ experience working in a cross-functional matrix team
Responsibilities
- Together with MSAT-DS and CMC-Development colleagues, evaluate and implement as appropriate innovative process architecture and process analytical technologies in 2nd generation programs.
- Develop proposal for CMC briefing package with supportive data and rationale for endorsement at MSAT governance forums.
- Member of CMC team for specific group of new products in commercial process development.
- Partner with managers and team leaders within DS and Analytical, CMC Development, and Regulatory Affairs to influence Sanofi practices for stage I validation and enable simplification of workflow.
- Work with MSAT DS and Analytical function heads to form 2nd generation process development sub team.
Preferred Qualifications
- Process development experience with mammalian expressed proteins
- Experience in leading cross-functional teams is preferred
- Experience in contributing to establishing control strategy and comparability strategy for biologics DS processes is a must
- Understanding of biologic product attributes, analytical methods in support of process design, control, and comparability
- Understanding of ICH guidelines in establishing process life cycle management strategies
- Some experience in technology transfer, scale-up, process validation and complex technical investigation in manufacturing
- Knowledge of manufacturability requirements including GMP, raw materials, resins and SUTs, process architecture in plants, cadence, cost of goods
- Knowledge of drug product requirement for drug substance
- Digital skills including use of productivity and collaboration tools, scientific data analysis, statistical and other tools for design of experiments, & process models for establishing design space and advanced process controls
- Proven Communication skills, oral and writing about complex topics to a variety of audiences internally and externally
- Highly motivated individual with the ability to work independently as well as on a crossfunctional and cross-site international teams