QC-Scientist, Bioassay

Seattle, WA, United States
Jul 25, 2021
Required Education
Bachelors Degree
Position Type
Full time
Just is seeking a motivated and creative scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The new scientist will join a fast-paced, collaborative, and multidisciplinary Quality Control team. This position will be responsible for bringing the QC-Bioassay laboratory (BSL2) on-line and will include: overseeing equipment qualification, authoring of SOPs, ensuring compliance with local safety and GxP regulations, qualification of methods to support GMP release and stability assessment of biotherapeutics. As a key senior member of the QC group, the successful candidate will have significant experience in cell-based methods with strong data analysis skills. Experience with immunoassay and qPCR method development /execution is highly desired. The ideal candidate has strong written and verbal communication skill, multitasks effectively, works well independently and in teams.

  • Oversee the daily activities of the QC Bioassay laboratory in support of large molecule release and stability analysis
  • Qualify cell based and other immunoassays for early and late stage biotherapeutics
  • Provide subject matter expertise during internal project team meetings and interactions with clients
  • Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved
  • Author SOPs, Quality analytical methods and LIMS ELN workbooks
  • Mentor and train junior staff
  • Provide technical support during analytical method transfer into the QC laboratory
  • Identify gaps, design collaborative solutions and implement laboratory improvements
  • Oversee laboratory investigations, deviations, OOS, and CAPAs.

Required Qualifications:
  • BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of 8 years of industry experience
  • Experience in the qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
  • Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product release / stability testing
  • Extensive knowledge of GdPs and GMPs
  • Strong oral and written communication skills
  • Proficient with the change order process and utilizing a QMS

    Preferred Qualifications:
    • Utilizing LIMS for sample management and data entry
    • Experience with SoftMax Pro for data analysis

    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