Responsibilities
- Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing.
- Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols.
- Mentor fellow team members on cGMP documentation protocols to ensure the highest standards.
- Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations.
- Author, revise, and maintain SOPs through Capricor’s document change system.
- Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations.
- Prepare technical summaries, protocols, and reports to ensure full documentation of production activities.
- Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance.
- Take on special projects in manufacturing and development as required.
Requirements
- Bachelor’s degree in Biomedical Engineering, Biological Sciences, or a related field.
- 1-3 years of experience in a cGMP/cGTP manufacturing environment.
- Solid laboratory experience in mammalian tissue culture, along with expertise in aseptic techniques.
- Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries.
- Strong organizational skills and acute attention to detail within a fast-paced, dynamic setting.
- Basic molecular biology and flow cytometry skills are a plus.
- Adaptability to work schedules that may include weekends or holidays as needed.
$25 - $30 an hour