Scientific Director or Principal Scientist, Bioreactor Process Design

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Job description

Just - Evotec Biologics is looking for a Scientific Director or Principal Scientist of Bioreactor Process Design to join a fast-paced, collaborative, and multidisciplinary team to lead bioreactor development at our Seattle site for the advancement of low-cost biotherapeutics manufacturing through the refinement and implementation of integrated, continuous bioprocessing. This position will oversee bioreactor development for both early and late stage processes and will include clone screening, process optimization, technology transfer, and process characterization for continuous perfusion and intensified fed-batch processes, as well as technology development to support end-to-end continuous bioprocessing. The idea candidate will have strong management and leadership skills as well as a deep understanding of mammalian cell culture and perfusion bioreactor development for the production of clinical and commercial therapeutic proteins. A proven track record of technical skills in this area, as well as experience in leading groups of scientists is required. Strong written and verbal communication skills are required, and experience in client and multi-site communication is preferred.

Responsibilities:

• Lead a diverse group encompassing all aspects of bioreactor process development, characterization, validation as well as tech transfer to cGMP manufacturing for perfusion and intensified fed-batch processes.
• Drive 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.
• Collaborate across the organization to accelerate clinical development timelines while reducing development costs.
• Manage staff, capital resources, and planning.
• Serve as a technical resource on cross functional teams for cell culture and bioreactor processes (small scale models, process transfer, and scale up) and authoring CMC regulatory sections.
• Act as an internal technical resource for Manufacturing and Process Design, as well as a resource and subject matter expert for external clients and partners.

Required qualifications:

• BS/MS in Engineering, Biochemistry, Molecular Biology, or related field with 15+ years of experience or Ph.D. with 7+years of experience.
• Expertise in bioreactor cell culture and perfusion technology 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 leading bioreactor development teams.
• Experience with high throughput cell culture (e.g. HT assays, robotics such as Ambr , lab automation, or multi-omic data is a plus)

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area.

Middle Management