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MANUFACTURING, SCIENCE and TECHNOLOGY

3 months ago

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

Position: Manufacturing, Science and Technology (MSAT) Associate I/II

Capricor is seeking a tenacious, science-oriented individual with a proficient knowledge of GMP manufacturing and an understanding of cell culture/cell therapies. The MSAT Associate I/II will need to learn/train quickly to provide Subject Matter Expert (SME) feedback for the various manufacturing processes. This position will support CMC operations focusing on all areas, including, but not limited to, process development/optimization, technology transfers, change controls, manufacturing operations, and creation/revision of controlled documents.


Responsibilities:

  • Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments
  • Training on the cell therapy and/or exosome platforms quickly to assist in compiling and scientific data relating to the cell therapy and/or exosome platforms
  • Assisting with all tech transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines
  • Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use
  • Creating/Revising (as needed) and reviewing all process-related manufacturing documentation (batch records, SOPs, bills of material, tech transfer documents, risk assessments and process flow diagrams) to assure all clinical products meet the requirements for quality, safety and efficacy
  • Performing manufacturing deviation investigations to determine help determine root cause and product impact
  • Providing in-person and real-time manufacturing production support as needed.
  • Identifying process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in collaboration with R&PD and manufacturing
  • Working closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations
  • Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset
  • Performing such other duties as may be assigned from time to time.


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 analyzation/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