Senior Manager, Bioreactor Process Development

Senior Manager, Bioreactor Process Development

Evotec

Toulouse, France

What You’ll Do:

• Leading a diverse group of scientists encompassing all aspects of cell culture and bioreactor process development, characterization, and validation as well as technology transfer to cGMP manufacturing for perfusion and intensified fed-batch processes;
• Collaborating across the organization to accelerate clinical development timelines, reduce development costs, and optimize strategies for process development and characterization for upstream bioreactor processes;
• Defining and driving the technology development strategy for process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in culture productivity, control of product quality, and data management while working with vendors and external partners;
• Serving as a Project Team Lead within the process development organization to execute on client projects that involve multiple functional areas and the full range of regulatory stages;
• Managing staff, training, capital resources, and planning within the department while supporting multiple client projects at various stages of process development and characterization;
• 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) in addition to authoring CMC regulatory sections;
• Clearly and effectively communicating scientific information, experimental plans, and data to internal project teams, cross-functional area teams, senior management, external clients, vendors, and technology development collaborators as well as the external scientific community such as regulatory agencies, review boards, publications, and conferences; may also be invited to present and lead scientific meetings, committees, and workstreams.

Who You Are:

• Expert in bioreactor cell culture and perfusion technology development and tech as well as CMC sections authoring for regulatory filings;
• Experienced in Biosimilar development;
• Experienced with commercial process development, process characterization, and validation;
• Expert in design of experiments (DOE) and statistical analysis;
• Experienced with high throughput cell culture (e.g. HT assays, robotics such as Ambr systems, lab automation, or multi-omic data) is a plus.

Pluses

• Experienced analyzing data in tools such as JMP, R, or Python;
• General understanding of cell biology, fluid dynamics, and biotransport as well as knowledge in other functional areas (downstream purification and analytical sciences);
• General understanding of circuits (grounding, power, signal, etc.);
• Experienced working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities);
• Master’s in engineering, Biochemistry, Biology, or related field with 12+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field with 10+ years of experience;
• Proficient in both verbal and written English is essential;
• Available to work on weekends and evenings is required.