Scientist will be a key contributor in the Process Science Downstream group responsible for advancing life cycle management (LCM) of Sanofi’s commercial portfolio. The successful candidate will utilize chromatography, membrane separation and filtration technologies to improve current commercial progress and develop 2nd generation process of monoclonal antibodies and recombinant proteins, with responsibilities spanning bench and pilot-scale process development & characterization activities, as well as support of technology transfer to manufacturing facilities. This individual will work in a team environment, collaborating with various colleagues in R&D, Manufacturing technical services, Quality and Regulatory organizations.
Work collaboratively within the Process Science team to design and execute experiments supporting process definition, optimization, characterization, scale-up, validation, and transfer activities.
Advise members of project teams in the design, execution and analysis of laboratory experimentation
Author and review development & characterization reports, as well as process validation and regulatory filing reports when needed
Actively communicate activities and progress by presenting at varied technical forums
Maintain full working knowledge of principles and theories, and advance our understanding and control in both current and the 2nd gen commercial processes
Keep abreast of novel platform technology, PAT tool, and industrial best practice, and evaluate their potential application across multiple programs within the organization when needed
Collaborate with Bioprocess Engineering & Data Analytics group to apply modeling tools to scale-up and scale-down manufacturing processes in support of lab to commercial scale development and validations studies
Work closely with manufacturing technical support teams to identify risks and map out opportunities for process improvements, Perform lab scale studies to support manufacturing deviations for root cause identification and CAPA implementation
Support LCM project or Tech Transfer teams for process design, process control strategy, process validation and facility fit for current and next generation processes
Supervise junior team members or lead small team as needed
Work is performed with minimal supervision and direction. Participates in determining objectives of assignment. Independently determines and develops approach to solution. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
Degree in engineering, engineering management or other relevant discipline
BS and 8years of professional experience
MS and 6 years of professional experience
PhD and 0 - 2 years of professional experience
• Hands-on experience at Laboratory, pilot or manufacturing scale for biological products
• Strong skills in data analytics and modeling methods and relevant software
• Strong experience in one or more areas of process development, process transfer, process scale-up and validation activities
• Good knowledge of use of structured methodologies in the areas related to downstream process design, scale-down model, process control strategies, scale-up, validation and continuous process verification as applied to mammalian-expressed proteins
• Solid understanding GMP commercial biologic manufacturing operations
• Some experience of working in a team environment with other technical staff
• Excellent scientific background and presentations skills