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Capricor Therapeutics

Posted 1 month ago

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Manufacturing Associate I

San DiegoOn-siteFull-time

AI Summary

Manufacturing Associate I performs routine GMP-compliant manufacturing tasks, maintains documentation, and supports data collection and SOPs in a cell culture-based production environment.

About this role

Responsibilities

  • Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing.
  • Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols.
  • Mentor fellow team members on cGMP documentation protocols to ensure the highest standards.
  • Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations.
  • Author, revise, and maintain SOPs through Capricor’s document change system.
  • Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations.
  • Prepare technical summaries, protocols, and reports to ensure full documentation of production activities.
  • Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance.
  • Take on special projects in manufacturing and development as required.

    • Requirements

  • Bachelor’s degree in Biomedical Engineering, Biological Sciences, or a related field.
  • 1-3 years of experience in a cGMP/cGTP manufacturing environment.
  • Solid laboratory experience in mammalian tissue culture, along with expertise in aseptic techniques.
  • Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries.
  • Strong organizational skills and acute attention to detail within a fast-paced, dynamic setting.
  • Basic molecular biology and flow cytometry skills are a plus.
  • Adaptability to work schedules that may include weekends or holidays as needed.

    • Skills

    Aseptic TechniquesBatch RecordsCAPA HandlingCell CountingCell CultureCentrifugationCGMP DocumentationCleanroom ProceduresDocumentation SystemsFlow CytometryFormulationGMP RegulationsInventory ManagementMolecular BiologySOP Writing

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