MSAT Associate

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is
Deramiocel
(CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary Stealth

X™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The MSAT Associate 2 supports cGMP manufacturing operations through technical writing, investigation management, and process-focused scientific problem solving. This role requires a strong understanding of cell therapy orbiologicsmanufacturing and a demonstrated ability to analyze data, manage quality events, and provide real-time support to production activities.

In this position you will act as a Subject Matter Expert (SME) across manufacturing processes, supporting technology transfer, continuous improvement, deviation investigations, and the development and revision of controlled documentation. This position partners closely with Manufacturing, QA, Process Development, and Supplier Quality to ensure compliant, efficient, and well‑documented operations.

• Providingsupportto MSAT Teamand working cross-functionallytoensure clear communicationacross various departments.
• Management of deviations and other quality records, performingroot causeinvestigations(6M, 5-Why’s,etc) todeterminecausal factorsandevaluateproduct impact.
• Trainingonthe celltherapy and/orexosome platformsquickly toassistinproduct impact assessments, andcompilingscientific data relatingtothemanufacturing processes.
• Assistingwithtech transfers intoc
  
  GMP Manufacturing,ensuring the transfer is controlled and executed within GMP regulatory guidelines.
• Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, andtimelymanufacture of biopharmaceuticalproductfor pre-clinical,clinical and commercial use.
• Assistingon revising(as needed) and reviewing process-related manufacturing documentation (batch records,SOPs, bills of material, process flow diagrams) toassureall clinical products meet the requirements for quality,safetyand efficacy.
• Providing in-person and real-time manufacturing production supportasneeded.
• Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances.
• Identifyingcontinuousimprovement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety whilemaintainingregulatory compliance incross functionalcollaborations.
• Working closely with Quality department to ensure compliance withc
  
  GMP,ICHand FDA regulations.
• Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, andan errorprevention/continuous improvement mindset.
• Performing such other duties as may be assigned to you from time to time.

• Bachelor’s degreeand2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience.
• A minimum of 1yearexperience in adherent cell culture.
  
  Additionalexperiencewithcells in suspension is a plus.
• Experience with writing/revisingtechnical documentsisrequired(SOPs, Forms, Batch Records,etc).
• Previous experience with,or knowledge/understanding of,variousquality eventsisrequired(Deviations, CAPAs, Change Controlsetc).
• Deep understanding ofcell culture and ability to troubleshoot commonprocessing issues.
• Experience with scale-up of cell therapy processes and closed manufacturing systems preferred.
• Ability to collect andassistin theanalyzation/trending ofdata and information todeterminepaths for process improvement and potential root cause.
• Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMPprinciplesand collaboration with others.
• Must have full working knowledge of cGMP regulations.
• Exceptional communication,…