Manufacturing Supervisor

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 StealthX™ 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. As a Manufacturing Supervisor, you will oversee the manufacturing team, ensuring cGMP-compliant production of biologic products for clinical trials. You will supervise daily operations, mentor staff, and collaborate with the Associate Director of Manufacturing to drive efficiency, quality, and regulatory adherence.

Responsibilities

· Supervise the manufacturing team, including Technicians, Associates (I-II, III, III-Lead), to ensure seamless execution of production tasks such as cell culture, media preparation, formulation, centrifugation, and freezing. · Ensure all manufacturing activities comply with cGMP standards, overseeing proper documentation, inventory management, and cleanroom operations. · Review and approve cGMP documentation, including batch records, logs, forms, and protocols, ensuring accuracy and adherence to Good Documentation Practices (GDP). · Monitor production processes, analyze data, and report on performance metrics to identify areas for improvement and ensure quality goals are met. · Coordinate with the Associate Director of Manufacturing to develop production schedules, allocate resources, and address operational challenges. · Lead training and mentoring of manufacturing staff, ensuring team competency in aseptic techniques, cGMP standards, and manufacturing procedures. · Oversee the initiation, investigation, and closure of deviations, CAPAs, and process improvements, ensuring timely resolution and documentation. · Author, review, and update standard operating procedures (SOPs) and other manufacturing documentation using the document change system. · Manage inventory, material transfers, and cleanroom setup/shutdown activities to support continuous manufacturing operations. · Facilitate cross-functional collaboration with Quality Control, Materials Management, and other departments to ensure production alignment with company objectives. · Lead special manufacturing and development projects as assigned by the Associate Director of Manufacturing. · Perform other duties as assigned to support manufacturing operations and company goals.

Requirements

· Bachelor’s degree in Biological Sciences, Biomedical Engineering, or related field; advanced degree preferred. · 6+ years of experience in a cGMP manufacturing environment, with at least 2-3 years in a supervisory or leadership role. · In-depth knowledge of cell culture, aseptic techniques, cGMP standards, and regulatory compliance in a biotech/pharma setting. · Proven expertise in Good Documentation Practices (GDP) and managing manufacturing documentation. · Experience leading deviation investigations, CAPAs, and process improvement initiatives. · Strong leadership and mentoring skills, with the ability to guide and develop a diverse manufacturing team. · Excellent organizational and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment. · Effective communication skills for cross-functional collaboration, training, and reporting to senior management. · Proficiency in data analysis, technical report writing, and presenting production metrics. · Ability to gown and work in classified cleanroom areas, ensuring compliance with ISO 7 standards.

Work Environment / Physical Demands · Primarily cleanroom-based with required time in GMP spaces overseeing manufacturing operations and team activities. · Requires prolonged periods of standing, computer use for documentation and reporting, and full gowning in ISO 7 cleanroom. · May involve lifting materials or equipment up to 20 pounds. · Ability to navigate cleanroom and GMP environments for production oversight and staff training.