Principal Scientist, Drug Product Design | Seattle, WA
Just is looking for a Principal Scientist in our Drug Product Design team to join a fast-paced, collaborative, and multidisciplinary group. The position requires a comprehensive understanding of all aspects of protein formulation development. A proven track record of technical skills, experience working with CMO’s, as well as experience leading scientific personnel at all skill levels.
- Develop stage appropriate formulations for all types of therapeutic proteins from FIH through commercial development.
- Develop lyophilized and liquid formulations of low and high concentration protein products
- Define molecular properties contributing to chemical and physical formulation instabilities encountered during development and devise formulation options to overcome the obstacles
- Collaborate with individuals and teams within Just to develop a commercial formulation platform
- Optimize development strategies that increase efficiency and de-risk FIH and commercial drug product
- Represent formulation development on project teams ensuring a successful partner/client interface
- Collaborate with partner groups across the Just organization including Process Development, Quality and Manufacturing.
- Develop and refine worldwide regulatory communication both written and face-to-face
- Act as an internal technical resource for Quality, Manufacturing and Process Design, as well as a resource and subject matter expert for external clients and collaborators
- Represent Just at external meetings related to important industry wide issues related to our business
- Publication of important scientific findings that advance the biopharmaceutical industry
- Ph.D. or equivalent experience in engineering or biological sciences
- Minimum 6+ years of post-graduate experience or equivalent in biotechnology, pharmaceutical or life science industry
- Recognized expert in formulation development of liquid and lyophilized protein biologics
- Knowledge of FDA and ICH regulatory guidance and requirements related to FIH and commercial formulation development
- Strong grasp of physical chemical/thermodynamic principles underpinning protein structure and stability, biotherapeutic quality attributes, CMC requirements, and QbD principles
- Knowledge of formulation development of RNA, DNA and cell based products is desirable
- Experience with UPLC, CE, various biophysical techniques, particle measurements and particle characterization techniques
- Experience with sterile drug product manufacturing
- Regulatory filings including IND/INDa/BLA
- Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are essential.
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. For job opportunities, learn more at www.just.bio/careers
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