Biotech GMP Manufacturing Associate I

Capricor Therapeutics; San Diego (CA); On-site; USD 71,635,000 - 85,962,000; Full time

Job summary

Capricor Therapeutics is seeking a Manufacturing Associate I to join our GMP-compliant production team in San Diego. You will perform routine tasks in a cleanroom, ensuring accuracy and adherence to cGMP standards as part of our cell and exosome-based therapy programs.

You will document activities meticulously, support CAPA processes, and collaborate to maintain production readiness for our Duchenne therapy programs.

Qualifications

• Bachelor's degree in Biomedical Engineering, Biological Sciences, or a related field.
• 1–3 years of experience in a cGMP/cGTP manufacturing environment.
• Solid lab experience in mammalian tissue culture with aseptic techniques.

Responsibilities

• Perform routine manufacturing tasks including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing.
• Complete and ensure timely, accurate documentation in GMP records, forms, and protocols.
• Mentor teammates on cGMP documentation practices to uphold quality standards.
• Plan, collect, analyze, and report production data with thorough records.
• Author, revise, and maintain SOPs in the document change system.
• Oversee inventory, material transfers, and cleanroom procedures to support GMP operations.
• Prepare technical summaries, protocols, and reports documenting activities.
• Lead moderate-complexity CAPAs and assist with deviations and investigations.
• Take on special projects in manufacturing and development as needed.

Skills

cGMP Manufacturing

Mammalian Tissue Culture

Aseptic Techniques

Regulatory Standards Knowledge

Documentation Skills

Attention to Detail

Education

Bachelor's degree in Biomedical Engineering / Biological Sciences or related field

Job description

Capricor Therapeutics is seeking a Manufacturing Associate I to join our GMP-compliant production team in San Diego. You will perform routine tasks in a cleanroom, ensuring accuracy and adherence to cGMP standards as part of our cell and exosome-based therapy programs.

You will document activities meticulously, support CAPA processes, and collaborate to maintain production readiness for our Duchenne therapy programs.