MSAT Associate

MSAT Associate 2

Capricor Therapeutics, Inc. is a biotechnology company dedicated to advancing transformative cell and exosome‑based therapies for rare diseases. Our lead cell‑therapy program, Deramiocel (CAP‑1002), is in late‑stage development for Duchenne muscular dystrophy, and our proprietary Stealth

X™ exosome platform is unlocking new possibilities in targeted delivery and vaccinology.

The MSAT Associate 2 supports cGMP manufacturing operations through technical writing, investigation management, and process‑focused scientific problem solving. The role requires a strong understanding of cell therapy or biologics manufacturing, data analysis, quality event management, and real‑time support to production activities.

$72,500.00/yr – $87,500.00/yr

• Provide support to the MSAT team and work cross‑functionally to ensure clear communication across various departments.
• Manage deviations and other quality records, performing root‑cause investigations (6M, 5‑Why’s, etc.) to determine causal factors and evaluate product impact.
• Train on cell therapy and/or exosome platforms to assist in product impact assessments and compile scientific data relating to manufacturing processes.
• Assist with technology transfers into cGMP manufacturing, ensuring transfers are controlled and executed within GMP regulatory guidelines.
• Support the Manufacturing group and troubleshoot production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre‑clinical, clinical and commercial use.
• Revise and review process‑related manufacturing documentation (batch records, SOPs, bills of material, process flow diagrams) to assure all clinical products meet quality, safety and efficacy requirements.
• Provide in‑person and real‑time manufacturing production support as needed.
• Collaborate with Supplier Quality and Manufacturing to evaluate change notifications or material non‑conformances.
• Identify continuous improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and maintain regulatory compliance.
• Work closely with the Quality department to ensure compliance with cGMP, ICH and FDA regulations.
• Serve as an organizational change agent and foster an atmosphere of questioning, empowerment and continuous improvement.
• Perform such other duties as may be assigned from time to time.

• Bachelor’s degree with 2+ years of hands‑on cGMP biologics manufacturing experience in the pharmaceutical/biotech industry preferred, or an equivalent combination of education and experience.
• Minimum 1 year of experience in adherent cell culture; experience with suspension culture is a plus.
• Experience writing/revising technical documents (SOPs, forms, batch records, etc.) required.
• Experience with quality events (deviations, CAPAs, change controls) required.
• Deep understanding of cell culture and ability to troubleshoot common processing issues.
• Preferred experience with scale‑up of cell therapy processes and closed manufacturing systems.
• Ability to collect and analyze/trend data to drive process improvement and root‑cause analysis.
• Demonstrated technical proficiency, scientific creativity, problem‑solving skills and strong GMP principles.
• Full working knowledge of cGMP regulations.
• Exceptional communication, presentation and interpersonal skills.
• Strong Microsoft Word and Excel skills.
• Ability to work in a dynamic environment, multi‑task, and meet aggressive deadlines.
• Ability to work independently and on larger cross‑department projects as part of a team.

• Professional GMP facility environment with controlled conditions.
• Ability to sit or stand for extended periods during training and operations.
• Occasional lifting of materials or equipment up to 40 pounds.
• Willingness to work inside an ISO7 cleanroom when supporting manufacturing operations.
• Compliance with gowning procedures and cleanroom protocols for aseptic activities.

Capricor Therapeutics is a trailblazer in cell and exosome therapy, redefining standards of care with innovative treatments grounded in scientific excellence. Guided by integrity and passion for patient‑centered impact, we are shaping a brighter future for healthcare. Join a mission‑driven team that is transforming lives with every breakthrough.

Not Applicable

Full‑time

Other

Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address ending in  Capricor will never ask potential employees to send a check or money for any reason.