Job Details

  • Title: Associate Purification Engineer / Scientist
  • Code: RCI-10510554
  • Location: Vacaville California (CA) 95688
  • Posted Date: 07/28/2020
  • Duration: 8 Months
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  Job Description

Provide daily management and coordination support to enable completion of purification related technical packages.

Responsibility includes:

  •  develop and execute logistics for analytical data supportive of purification technical studies. This includes: coordination with Manufacturing, Process Engineering, Quality Control, and Process Technical Development on non-routine sampling request, sample aliquoting, sample shipment, testing lab coordination, and test results compilation
    •   collaborate within Process Engineering and Quality Assurance to translate at-scale manufacturing runs genealogy into run context
  • develop and execute translation of electronic batch records into process summary
    •   perform data verification of translated information from electronic batch records into process summary
    •   prepare technical package for data summary and supportive information to support the conclusion of technical studies
    •   provide support on technical documentation logistics
    •   create and maintain visual management to track activities group activities for ease of reporting during team huddle

    Occasionally, the position may involve some work during non-business hours.

Previous large-scale biopharmaceutical manufacturing experience, especially in mammalian cell culture or purification processing

  • • Must be able to clearly communicate information to a varied audience and good technical writing skills
    • Effective communication and  interpersonal skills with technical,  operations, quality  personnel as well as project/process engineering  personnel
    • Thorough understanding  and application of cGMP, particularly as they relate to the Good Documentation Practices (GDP) and data integrity
    • Outstanding organization and attention to detail
    • Ability to adapt to changing priorities
    • Ability to work independently, seek stakeholders input, and drive assignments to completion
    • Knowledge or previous experience on monoclonal antibody production processes and statistics (including the use of statistical software such as JMP) is highly desirable