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Supervisor, Manufacturing DownstreamAvid Bioservices • Tustin, California, United States
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Supervisor, Manufacturing Downstream

Avid Bioservices
  • US
    Tustin, California, United States
  • US
    Tustin, California, United States
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À propos

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.   Your Role:   The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
  • Schedule, plan and coordinate production activities.
  • Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.
  • cGMP documentation.
  • Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
  • Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
  • Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
  • Coordinate manufacturing, validation, and maintenance activities with supporting departments.
  • Oversee the setup of new manufacturing processes and critical equipment.
  • Identify the technical, procedural and equipment issues that hinder production and compliance.
  • Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
  • Assist in the
  • Tustin, California, United States

Compétences linguistiques

  • English
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