Position: Manufacturing Associate I/II

This position will be a part of our Manufacturing team performing cGMP manufacturing to support Capricor’s clinical trials and exosome development. Individuals with a scientific background, mammalian cell culture and cGMP experience needed.

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
• 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
• From time-to-time extended hours may be required with or without notice, dependent on the work needed

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