QC-Scientist, Bioassay

Location
Redmond, WA
Posted
Jun 16, 2022
Ref
REQ-05537
Hotbed
BioForest
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 supporting the process to bring 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.

Responsibilities:

  • Help lead 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
  • Responsible for transfer and validation of methods originating from internal or client Development Laboratories into Quality Control (QC) in compliance with global regulatory requirements
  • 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
  • Implement method lifecycle and method maintenance programs to support bioassay and cell-based methods
  • Partner with clients in the design of development and qualification studies, selection and characterization of critical reagents, and method optimization initiatives

Required Qualifications:

  • BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of 8 years of GMP 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
  • Excellent analytical, technical writing, communication and data management skills
  • Extensive experience with the change order process and utilizing a QMS
  • Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team
  • Ability to understand analytical/technical data
  • Good organizational skills with attention to detail
  • Ability to interact constructively with co-workers

Preferred Qualifications:

  • Utilize Laboratory Information Management System (LIMS) for sample management and data entry
  • Experience with SoftMax Pro for data analysis
  • Experience with implementation of automated platforms is preferred
  • Experience with implementing bioassay methods in a commercial QC facility
  • Demonstrated experience in method lifecycle management in a commercial environment is desired
  • Experience training QC analysts in method execution and instrument operation and strong technical writing experience (SOPs, Method Validation Protocols and Reports)


Worker