Manufacturing Associate

2 months ago

San Diego, California, United States Capricor Inc Full time
Job Summary

Capricor Inc is seeking a highly skilled and detail-oriented Manufacturing Associate to join our team. As a key member of our Manufacturing, Science and Technology (MSAT) department, you will be responsible for supporting the development and implementation of cGMP manufacturing processes.

Key Responsibilities
  • Process Development and Optimization: Collaborate with cross-functional teams to design, develop, and optimize cGMP manufacturing processes, ensuring compliance with regulatory guidelines.
  • Technical Transfer and Documentation: Assist in the transfer of manufacturing processes into cGMP facilities, ensuring seamless execution and documentation of all technical transfer activities.
  • Manufacturing Operations and Quality Assurance: Support the Manufacturing group in troubleshooting production activities, ensuring safe, quality, and timely manufacture of biopharmaceutical products.
  • Documentation and Record-Keeping: Create, revise, and review process-related manufacturing documentation, including batch records, SOPs, bills of material, and risk assessments.
  • Deviation Investigations and Root Cause Analysis: Conduct thorough investigations to determine root cause and product impact of manufacturing deviations.
  • Process Improvement and Optimization: Identify opportunities for process improvement and implement corrective actions to increase yield, maximize capacity, and reduce costs.
  • Regulatory Compliance and Quality Management: Ensure compliance with cGMP, ICH, and FDA regulations, working closely with the Quality department to maintain high standards of quality and safety.
  • Collaboration and Communication: Foster a culture of collaboration and open communication, working closely with cross-functional teams to achieve common goals.
Requirements
  • Education and Experience: Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in the pharmaceutical/biotech industry, or equivalent combination of degree/experience.
  • Cell Culture and Manufacturing Experience: Minimum of 1 year experience in adherent cell culture, with additional experience in cells in suspension a plus.
  • Technical Writing and Documentation: Experience with writing and revising technical documents, including SOPs, forms, batch records, and risk assessments.
  • Quality Events and Compliance: Previous experience with, or knowledge of, various quality events, including deviations, CAPAs, and change controls.
  • Communication and Interpersonal Skills: Exceptional communication and interpersonal skills, with ability to collect and analyze data to determine paths for process improvement.
  • Technical Proficiency and Problem-Solving: Demonstrated technical proficiency, scientific creativity, problem-solving skills, and strong GMP principles.
  • Regulatory Knowledge and Compliance: Full working knowledge of cGMP regulations and ability to work in a dynamic environment, meeting aggressive deadlines.

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