QC Associate II

Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.

About The Role

We are seeking a highly motivated Quality Control Associate I/II to join our team. In this role, you will perform QC testing on existing products, coordinate sample shipping for outsourced testing, analyze data, and complete quality control documentation. You will also collaborate with the development team to create new assays and analytical methods for innovative regenerative therapeutics, including cells and exosomes.

Key Responsibilities

• Perform QC analysis on in-process intermediates, bulk drug substances, and final drug products to support batch disposition.
• Coordinate with outsourced laboratories to ensure timely sample testing and result reporting.
• Prepare and maintain mammalian cell cultures.
• Perform data analysis, maintain organized records and reports, and ensure timely database updates.
• Write technical documentation, including deviations, qualification/validation protocols, and OOS investigations.
• Collaborate with the Process/Analytical Development team to troubleshoot and optimize assays.
• Train other team members on relevant techniques and procedures as needed.
• Write or revise Quality Control Standard Operating Procedures (SOPs).
• Conduct Environmental Monitoring of the manufacturing facility.
• Coordinate with third-party vendors to maintain equipment calibration.
• Work closely with Manufacturing and Quality Assurance teams to resolve issues.
• Present data at internal meetings.
• Receive and inspect materials.
• Work independently to meet project goals.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Biological Sciences or a related field.
• 2+ years of experience in a GMP Quality Control laboratory or a combination of GMP/GLP experience preferred.
• Proficiency in mammalian cell culture and molecular biology techniques.
• Experience with laboratory methods, including flow cytometry, Western Blot, qPCR, RNA/DNA isolation, ELISAs, and endotoxin detection.
• Experience with method qualification/validation is preferred.
• Strong ability to perform laboratory analysis, troubleshoot, and improve methods independently.
• Demonstrated history of successful independent laboratory work.
• Excellent communication, time management, and teamwork skills.
• Proficiency with Outlook, MS Office, and electronic systems.
• Ability to gown and work in a classified area; aseptic processing experience is a plus.

Work Environment / Physical Demands

• Ability to sit and stand for extended periods.
• Must be able to lift and carry materials up to 40 pounds and move about the office.

Compensation (USD)

• This role offers competitive compensation based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development.

Location Policy

This position is based at our headquarters, with flexibility for occasional remote work as needed.

Come Work With Us!

Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment.

If you’re excited about advancing cutting-edge therapies in the biotech industry, we’d love to hear from you!