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Downstream Manufacturing Associate Scientist

Company: Bayside Solutions
Location: Fremont
Posted on: May 10, 2022

Job Description:

Job Description Position Summary: The Downstream Manufacturing Associate Scientist will actively contribute to the manufacturing and technology transfer projects at the Fremont location. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting. The role will support GMP readiness and manufacturing activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design. Essential Duties and Responsibilities:

  • Execute complex unit operations in GMP manufacturing suites, including but not limited to chromatography, TFF, depth filtration, virus filtration, and buffer preparation, under the supervision of qualified personnel.
  • Maintain your own training within the parameters of compliance.
  • Equipment troubleshooting, pilot scale material generation, non-GMP tox material generation, and GMP downstream manufacturing activities are all supported.
  • Per project requirements, write/review/approve technical documents such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents.
  • Documents operate in accordance with cGMP and cGDP.
  • Follows cGMP established by site and adheres to established regulations.
  • Keep cleanroom standards, practices, and housekeeping in accordance with SOPs.
  • Recognize any minor issues with the equipment and immediately notify leads/managers of any issues or discrepancies.
  • Assess the impact of product issues and nonconformities on product safety and efficacy, as well as project milestones.
  • Contributes to quality activities such as investigations and walk-throughs, as well as support for authoring deviations, CAPA, and change control.
  • Other duties as assigned, as well as the ability to work in shifts Working Conditions:
    This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently. Qualifications
    BS in Life Sciences, or related discipline with 1-2 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturingWorking knowledge of industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)Experience with process monitoring software and equipment software (UNICORN, Pi Historian)Creative thinker that can identify better and more efficient methods to address issues and gapsDemonstrate ability to work independently and on cross-functional teamsAbility to prioritize assignments and to manage multiple projects simultaneously.

Keywords: Bayside Solutions, Fremont , Downstream Manufacturing Associate Scientist, Other , Fremont, California

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