Manufacturing Associate

7 days ago

San Diego, California, United States Capricor Inc Full time
Job Title: Manufacturing, Science and Technology Associate

Capricor Inc is seeking a highly skilled and motivated individual to join our team as a Manufacturing, Science and Technology Associate. This role will provide support to our MSAT team and work cross-functionally to ensure clear communication across various departments.

Key Responsibilities:
  • Provide subject matter expert feedback for various manufacturing processes
  • Train on cell therapy and/or exosome platforms to assist in compiling and scientific data
  • Assist with tech transfers into cGMP manufacturing, ensuring controlled and executed transfers within GMP regulatory guidelines
  • Support manufacturing group and troubleshoot production activities to ensure safe, quality, and timely manufacture of biopharmaceutical products
  • Create and revise process-related manufacturing documentation to ensure clinical products meet quality, safety, and efficacy requirements
  • Perform manufacturing deviation investigations to determine root cause and product impact
  • Provide in-person and real-time manufacturing production support as needed
  • Identify process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
  • Work closely with Quality department to ensure compliance with cGMP, ICH, and FDA regulations
  • Serve as an organizational change agent and foster an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset
Requirements:
  • Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience
  • A minimum of 1 year experience in adherent cell culture. Additional experience with cells in suspension is a plus
  • Experience with writing/revising technical documents is preferred (SOPs, Forms, Batch Records, etc)
  • Previous experience with, or knowledge/understanding of, various quality events is preferred (Deviations, CAPAs, Change Controls etc)
  • Deeper understanding of cell culture and ability to trouble-shoot common processing issues
  • Exceptional communication and interpersonal skills
  • Ability to collect and assist in the analysis/trending of data and information to determine paths for process improvement and potential root cause
  • Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles, and collaboration with others
  • Must have full working knowledge of cGMP regulations
  • Exceptional communication and interpersonal skills
  • Ability to work in a dynamic environment, multi-task, and meet aggressive deadlines
  • Demonstrated critical thinking and problem-solving skills
  • Ability to work independently, as well as work on larger cross-department projects as a team

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