Capricor Therapeutics
Biotech
ManufacturingSupervisor
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“Manufacturing Supervisor at Capricor Therapeutics. Skills: CGMP manufacturing, Cell culture, Aseptic techniques, Team supervision. Supervise manufacturing team. Ensure cGMP-compliant production”
Industry & Context.
Problem-solving skills
Ability to gown, Work in classified cleanroom, Prolonged periods of standing, Computer use for documentation, Full gowning in ISO 7 cleanroom, Lifting materials up to 20 pounds, Navigate cleanroom environments, Navigate GMP environments
What They're Looking For.
Must Have
6+ years cGMP manufacturing experience, 2-3 years supervisory experience, In-depth knowledge of cell culture, In-depth knowledge of aseptic techniques, In-depth knowledge of cGMP standards, In-depth knowledge of regulatory compliance, Proven expertise in Good Documentation Practices, Experience leading deviation investigations, Experience leading CAPAs, Experience leading process improvement initiatives, Ability to gown and work in classified cleanroom areas, Compliance with ISO 7 standards
Nice to Have
Bachelor’s degree in Biological Sciences, Bachelor’s degree in Biomedical Engineering, Related advanced degree preferred
What You'll Do.
Supervise manufacturing team
Ensure cGMP-compliant production
Supervise daily operations
Collaborate with Associate Director
Ensure seamless execution of production tasks
Ensure manufacturing activities comply with cGMP
Oversee proper documentation
Oversee inventory management
Oversee cleanroom operations
Review and approve cGMP documentation
Monitor production processes
Analyze production data
Report on performance metrics
Coordinate production schedules
Address operational challenges
Lead training of manufacturing staff
Lead mentoring of manufacturing staff
Ensure team competency in aseptic techniques
Ensure team competency in cGMP standards
Ensure team competency in manufacturing procedures
Oversee initiation of deviations
Oversee investigation of deviations
Oversee closure of deviations
Oversee initiation of CAPAs
Oversee investigation of CAPAs
Oversee closure of CAPAs
Oversee initiation of process improvements
Oversee investigation of process improvements
Oversee closure of process improvements
Author standard operating procedures
Review standard operating procedures
Update standard operating procedures
Manage material transfers
Manage cleanroom setup
Manage cleanroom shutdown
Facilitate cross-functional collaboration
Lead special manufacturing projects
Lead development projects
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Quality Control; Materials Management
Communication Scope
Reporting to senior management; Presenting production metrics
Full Job Description
## Description 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, a
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