MANUFACTURING ASSOCIATE 1 or 2

3 weeks ago


San Diego, United States Capricor Inc Full time
Job DescriptionJob Description

Position: Manufacturing Associate I/II


This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support Capricor’s clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.


Responsibilities:

  • Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
  • Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
  • Compiling data for documentation of test procedures and reporting abnormalities
  • Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
  • Authoring, revising and updating standard operating procedures using the document change system
  • Maintaining broad knowledge of state-of-the-art principles and theories
  • Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
  • Preparing technical summaries, protocols and reports
  • Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
  • Performing special manufacturing and development projects


Requirements:

  • Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
  • 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
  • Laboratory experience in mammalian tissue culture is required
  • Excellent aseptic technique, knowledge of aseptic practices
  • Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
  • Exceptional communication and interpersonal skills
  • Excellent organizational skills and attention to detail
  • Ability to work in a dynamic environment
  • Basic molecular biological and flow cytometry skills are preferred
  • Adaptable/flexible with work schedule with an ability to multi-task and prioritize work

Work Environment/Physical Demands:

  • Must be able to sit and stand for extended periods.
  • Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
  • Able to fully gown and work in a manufacturing area.
  • Work extended or off hours depending on the company needs to respond to manufacturing schedule (including weekends, holidays), as required



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