Senior Scientist, Purification Process Design

Location
Redmond, WA, United States
Posted
May 04, 2021
Ref
311628
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Just Evotec Biologics is seeking a motivated and creative senior scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. This scientist/engineer will join a fast-paced, collaborative, and multidisciplinary team to develop purification processes to support manufacturing at the 500-1000L scale for the advancement of low-cost biotherapeutics. As a key member of the Purification group, the successful candidate will have significant experience in developing downstream processes including primary capture, polishing chromatography, virus filtration and UF/DF. The ideal candidate should have strong experimental design and data analysis skills and experience mentoring junior staff. The ideal candidate also has strong written and verbal communication skills, works well independently and in teams, and is excited about improving processes and technology.

Responsibilities:
  • Work in teams to develop purification processes for early and late stage biotherapeutics manufacturing and biosimilars
  • Transfer processes to clinical and commercial manufacturing facilities
  • Author documents to support regulatory filing
  • Advance technologies to reduce the cost and improve the efficiency of development and manufacturing
  • Supervise and mentor associates

Required qualifications:
  • BS + 10 years experience, MS + 5-7 years experience, or Ph.D + 2 years experience in Engineering, Biochemistry or related field
  • Expertise in purification processes (protein A, polishing chromatography, filtration and UF/DF), including scale-down and scale-up strategies
  • Significant experience with design of experiments (DOE) and analysis using statistical software packages (JMP, MATLAB, etc.)
  • Experience with process transfer to clinical and commercial facilities
  • Experience with early & late stage regulatory filings

Preferred qualifications
  • Managerial experience
  • Experience with commercial process development, characterization, and validation
  • Experience with high throughput purification techniques (e.g. plate based robotics)
  • Experience with CMC and purification team leadership
  • Strength in data science, informatics, and/or automation
  • Experience authoring regulatory documents (e.g. IND/BLA) a plus
  • Programming and data analysis with JMP, R, and/or Python
  • Experience developing purification processes for biosimilars

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 200 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