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:
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Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
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Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
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Compiling data for documentation of test procedures and reporting abnormalities
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Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
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Authoring, revising and updating standard operating procedures using the document change system
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Maintaining broad knowledge of state-of-the-art principles and theories
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Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
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Preparing technical summaries, protocols and reports
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Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
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Performing special manufacturing and development projects
Requirements:
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Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
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1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
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Laboratory experience in mammalian tissue culture is required
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Excellent aseptic technique, knowledge of aseptic practices
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Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
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Exceptional communication and interpersonal skills
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Excellent organizational skills and attention to detail
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Ability to work in a dynamic environment
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Basic molecular biological and flow cytometry skills are preferred
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Adaptable/flexible with work schedule with an ability to multi-task and prioritize work
Work Environment/Physical Demands:
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Must be able to sit and stand for extended periods.
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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.
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Able to fully gown and work in a manufacturing area.
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Work extended or off hours depending on the company needs to respond to manufacturing schedule (including weekends, holidays), as required