Manufacturing Associate I

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.