Senior Scientist, Purification Process Development

Senior Scientist, Purification Process Development

Evotec

Toulouse, France

What You’ll Do:

• Driving all aspects of purification process development, characterization, and technology transfer to cGMP manufacturing for hybrid and continuous processes;
• Serving as an internal technical resource for cGMP manufacturing and Process Design as well as a resource and subject matter expert for external clients and partners for cell culture and bioreactor processes (small scale models, process transfer, and scale up) and authoring CMC regulatory sections;
• Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, senior management, external clients, vendors, and technology development collaborators;
• Independently designing, executing, and analyzing statistically designed experiments (DOE);
• Authoring work instructions, reports, and slides which summarize, organize, and interpret experiment results with review by appropriate team members;
• Training, staff and interns;
• Driving technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in culture productivity, control of product quality, and data management.

Your profile:

• Master’s degree in engineering, Biochemistry, Biotechnology or related field with 8 + years of experience or PhD with 5+ years of experience;
• Proficiency in both verbal and written English is essential;
• Expertise in purification technology and process development, transfer to cGMP manufacturing plants, and authoring CMC sections of regulatory filings;
• Experience with commercial process development, process characterization, and validation;
• Expertise in design of experiments (DOE) and statistical analysis;
• Experience in training, mentoring, supervising team members, leading development teams for external client projects and collaborations and internal technology development initiatives in a matrix-based system. 

Pluses:

• Experience with high throughput process development systems is a plus;
• Experience analyzing data in tools such as JMP, R, or Python;
• General understanding of cell biology, fluid dynamics, and protein chemistry as well as knowledge in other functional areas (upstream and analytical sciences);
• Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities).