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:
- 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