Manufacturing Associate I

As a Manufacturing Associate I, you’ll be a vital part of Capricor’s efforts in delivering therapies for patients in need. Supporting critical clinical trials and exosome development, you’ll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You’ll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor’s therapeutic success.

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.