Production Scientist (Manufacturing)

    • Job Tracking ID: 170086
    • Job Location: Seattle, WA
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: July 26, 2017
    • Years of Experience: Not Applicable
    • Starting Date: ASAP
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Job Description:

ARE YOU ADAPTIVE? We’re driving groundbreaking research in cancer and other immune-mediated diseases that translates into novel clinical diagnostics and innovative therapeutics. We are at the forefront of immune-based discoveries, transforming the future state of health through our disruptive, proprietary immunosequencing technology. With strong financial footing and rapid growth, we are looking for the brightest, most passionate and collaborative innovators to join us.

At Adaptive, you'll be challenged, you'll be inspired, and you'll be proud to be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you'll find a diverse, team-driven, fun culture where your contributions truly count. #BeingAdaptive

POSITION OVERVIEW

The Production Scientist I (Manufacturing) position will be responsible for the manufacture of laboratory reagents under GMP processes. The successful candidate will work within the Laboratory Ops team to provide high quality, regulated reagents for use in the Production Laboratory.

DUTIES AND RESPONSIBILITES

  • Perform reagent manufacturing under Good Manufacturing Practice (GMP) protocols
  • Manage SOPs and Master Batch Records (MBR) related to manufacture of reagent sub-components and final components
  • Work directly with Supply Chain team to complete chain of custody of materials
  • Work directly with Quality team to QC and release intermediate components for manufacture or use
  • Keep detailed MBRs in compliance with necessary regulations (FDA, ISO, etc)
  • Provide all MBRs or raw components records to Quality for storage and tracking
  • Develop new methods for improving reagent assembly and work with Process Engineering team on automated methods
  • Enter and track data in a laboratory information database (LIMS)
  • Ensure laboratory compliance with regulatory agencies (CLIA, CAP, FDA)
  • Manage inventory of raw materials and issue and track usage of finished materials
  • Use ERP system (NetSuite) to develop manufacturing records linked to inventory control
  • Provide training to manufacturing associates

Experience and Skills:

  • Education: BS degree in Biology, Molecular Biology, Immunology or Medical Technologist from an accredited institution.
  • Years of experience: Minimum of six years of laboratory experience and a three years of experience in GMP, ISO, or FDA manufacturing setting
  • Specialized knowledge and skills:
  • Experience in either a clinical (CLIA/CAP), high-throughput or manufacturing environment is preferred.
  • Experience with MRP/ERP software for tracking and documentation (e.g. NetSuite)
  • Working knowledge of laboratory terminology, equipment and supplies
  • Ability to maintain organized, detailed records and produce accurate reports.
  • The ability to be self-motivated and work independently, with minimal supervision, while also working as part of a team environment in a dynamic organization.
  • Strong interpersonal and communication skills, both written and spoken.
  • Flexibility and willingness to work in excess of standard hours when necessary, including nights & weekends