Capricor Therapeutics jobs in San Diego, CA - 63 jobs

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. 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 or biologics manufacturing 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. Responsibilities Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments. Management of deviations and other quality records, performing root cause investigations (6M, 5-Why's, etc) to determine causal factors and evaluate product impact. Training on the cell therapy and/or exosome platforms quickly to assist in product impact assessments, and compiling scientific data relating to the manufacturing processes. Assisting with tech transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines. Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use. Assisting on revising (as needed) and reviewing process-related manufacturing documentation (batch records, SOPs, bills of material, process flow diagrams) to assure all clinical products meet the requirements for quality, safety and efficacy. Providing in-person and real-time manufacturing production support as needed. Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances. Identifying continuous improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in cross functional collaborations. Working closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations. Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset. Performing such other duties as may be assigned to you from time to time. Requirements Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience. A minimum of 1 year experience in adherent cell culture. Additional experience with cells in suspension is a plus. Experience with writing/revising technical documents is required (SOPs, Forms, Batch Records, etc). Previous experience with, or knowledge/understanding of, various quality events is required (Deviations, CAPAs, Change Controls etc). Deep understanding of cell culture and ability to troubleshoot common processing issues. Experience with scale-up of cell therapy processes and closed manufacturing systems preferred. Ability to collect and assist in the analyzation/trending of data and information to determine paths for process improvement and potential root cause. Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles and collaboration with others. Must have 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, as well as work on larger cross-department projects as a team. Work Environment & Physical Demands 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. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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 Associate I/II, you'll be a vital part of Capricor's efforts in delivering therapies for patients in need. Supporting critical clinical trials and exosome development, you'll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You'll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor's therapeutic success. Responsibilities Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing. Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols. Mentor fellow team members on cGMP documentation protocols to ensure the highest standards. Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations. Author, revise, and maintain SOPs through Capricor's document change system. Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations. Prepare technical summaries, protocols, and reports to ensure full documentation of production activities. Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance. Take on special projects in manufacturing and development as required. Requirements Bachelor's degree in Biomedical Engineering, Biological Sciences, or a related field. 1-3 years of experience in a cGMP/cGTP manufacturing environment. Solid laboratory experience in mammalian tissue culture, along with expertise in aseptic techniques. Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries. Strong organizational skills and acute attention to detail within a fast-paced, dynamic setting. Basic molecular biology and flow cytometry skills are a plus. Adaptability to work schedules that may include weekends or holidays as needed. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. We are looking for an exceptional individual to join our growing team as a Shipping Associate is responsible for performing routine shipping and receiving activities to support commercial manufacturing, quality, and research operations. This role ensures the timely and accurate processing of outbound shipments and inbound deliveries while maintaining compliance with company procedures, regulatory requirements, and safety standards. Work ScheduleGiven the nature of this role and the Company's seven-day operational requirements, your position will follow a schedule that includes weekend work. Your exact schedule and shift times will be determined by the Company based on business needs and may vary depending on operational priorities. Weekend shifts are a required condition of employment for this role. While the Company will make reasonable efforts to provide advance notice of any changes, you acknowledge that your schedule may be subject to adjustment from time to time to support production timelines, inventory demands, and other critical business objectives. Flexibility in scheduling is essential to ensure uninterrupted operations and to meet customer and organizational commitments. Responsibilities Prepare, pack, and ship materials, components, and finished goods according to company SOPs and regulatory guidelines (e.g., GMP, GDP). Verify accuracy of shipping documentation, including packing lists, invoices, and shipping labels. Coordinate with carriers and logistics partners to schedule pickups and track shipments. Receive incoming materials, inspect for damage, and verify against purchase orders. Collect and receive finished goods with flexible schedule Maintain accurate inventory records in ERP system (e.g. NetSuite). Ensure proper handling and storage of temperature-sensitive and hazardous materials. Assist in maintaining shipping supplies and equipment in good condition. Support compliance with DOT, IATA, and other applicable shipping regulations. Perform other duties as assigned to support Supply Chain operations. Requirements High school diploma or equivalent. 1+ year experience in shipping/receiving or warehouse operations, preferably in a GMP-regulated environment Familiarity with ERP systems and shipping software. Knowledge of domestic and international shipping regulations (DOT, IATA) is a plus. Ability to lift to 50 lbs and work in a fast-paced environment. Strong attention to detail and organizational skills. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

About Capricor Therapeutics 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. Position Overview The Supplier Quality Specialist/Supervisor is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring compliance with Good Manufacturing Practice (GMP) standards. This position will drive supplier qualifications, conduct risk-based audits, and collaborate with cross-functional teams to maintain high-quality standards and support continuous improvement. The ideal candidate is a detail-oriented professional with extensive experience in supplier quality management and GMP/GLP environments, capable of working independently to meet project goals while ensuring regulatory compliance. This role will play a pivotal part in upholding Capricor's commitment to quality and excellence in the development of innovative therapies. The team this person will be joining develops and maintains the Supplier Quality Program, conducts supplier qualifications and audits, manages SCAR activities, generates and manages Quality Agreements, and develops SOPs. Responsibilities * Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain. * Manage Audit Programs: Establish and oversee Capricor's external audit programs to ensure compliance with regulatory standards. * Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability. * Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards. * Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality. * Manage SCAR Activities: Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues. * Generation and Management of Quality Agreements: Author, negotiate, and maintain Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations. * Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications. * Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making. * Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges. * Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance. * Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes. * Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency. * Train Employees: Provide training on relevant quality procedures to ensure consistent adherence across teams. * Develop SOPs: Write or revise QA/QC/Supply Chain Standard Operating Procedures (SOPs) to maintain compliance. * Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives. * Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines. * Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance. * Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives. Requirements * Education: Bachelor's degree in a relevant Biological Science discipline required. * Experience: 8+ years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits. * Lead Auditor Experience: Proven experience conducting audits as a lead auditor, ensuring compliance with internal and external quality standards. * Supplier/Vendor Qualification: 8+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring. * SCAR Management: Extensive experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues. * SOP Development: Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance. * Supplier Quality Agreements: Demonstrated expertise in authoring, negotiating, and maintaining Supplier Quality Agreements to clearly define roles, responsibilities, and quality expectations. * Technical Skills: Proficiency in Outlook, MS Office, and other electronic systems; experience with aseptic processing a plus. * Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively across departments. * Organizational Skills: Strong organizational skills and attention to detail to manage records, reports, and databases. * Multitasking: Ability to prioritize and manage multiple responsibilities in a fast-paced environment. * Work Environment Adaptability: Ability to gown and work in classified areas for audits or inspections. * Independent Work: Ability to independently perform tasks, generate reports, and escalate issues as needed. * ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe. * Strong team player with the ability to collaborate effectively across cross-functional departments. Work Environment and Physical Demands * Setting: Primarily office- and laboratory-based, focusing on supplier quality management, audits, and documentation, in an office or hybrid arrangement due to limited office space. * Physical Requirements: Requires gowning and working in classified areas; involves prolonged periods of computer use for data analysis, report generation, and SOP development; occasional lifting of office materials or equipment up to 20 pounds. * Travel: Occasional travel may be required for supplier audits or vendor meetings. Why Capricor? Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that's changing lives-help us shape the future of healthcare. This role offers the ability to develop and execute vendor programs that align with the organization's vision and growth objectives. You will develop partnerships where vendor insights, expertise, and strategic perspectives are recognized and valued. Compensation (USD) * Salary: Commensurate with experience. * Benefits: Comprehensive benefits package, including health insurance, retirement plans, equity awards, and opportunities for professional development. Come Work with Us! At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.

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 Technician, you'll be a vital part of Capricor's efforts in delivering therapies for patients in need. Supporting critical clinical trialscommercial production, you'll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You'll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor's therapeutic success. This role is a full time position on our Manufacturing team, this position will be a 2-2-3 work schedule. Responsibilities Maintaining cleanroom inventory, performing material transfers and cleanroom-required activities to support cGMP operations (i.e restocking Kanban, scrubs, and gowning) Ensuring clear communication and working closely with manufacturing and materials management to confirm proper materials are stocked accordingly; Performing cleanroom setup and shutdown (Biohazard waste decontamination, packaging and autoclaving of required materials/supplies, etc) Performing special manufacturing projects Completing required documentation with proper cGMP recording of entries and comments on batch records, forms and protocols independently; Operation, Maintenance, and Cleaning of GMP equipment, including: Centrifuges, Microscopes, Incubators, BSCs, Refrigerators, Freezers, etc Initiate minor revisions to existing documents, to troubleshoot simple existing procedures, and to contribute to continuous improvement initiatives. Performing such other duties as may be assigned from time to time. Requirements High school diploma or GED required Bachelor's degree in Biology, Biological Sciences or related field preferred 0-1 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting Lift, push, pull and carry up to 40 lbs. Excellent knowledge of aseptic technique and aseptic practices Excellent knowledge of Good Documentation Practices Exceptional communication and interpersonal skills Excellent organizational skills and attention to detail Excellent interpersonal skills, team player Ability to work in a dynamic environment Adaptable/flexible with work schedule with an ability to multi-task and prioritize work From time-to-time extended hours may be required with or without notice, dependent on the work needed Occasional weekend work may be required Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor 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. We are seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes batch record review, review of raw materials, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving companywide GLP/GCP/GMP controlled documentation, training, and facility support systems. This role is located at Capricor's headquarters in San Diego, CA.Responsibilities: Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system Coordinate / track / archive: controlled records (i.e., batch / test records, logbooks, validation documents, labels, reports, forms, etc) for change controls, deviations, CAPAs, audits, training, equipment calibration and preventative maintenance Write and/or review policies, standards, procedures and work instructions to document Quality documentation processes and practices Support supplier and material management, including ordering, incoming receipt, record keeping etc. Perform review and release of incoming materials. Inventory database management including accurate and timely updating of lot numbers and quantities Collaborate on development / improvement and implementation of material, facility and quality management systems Other required duties as may be assigned Requirements: Bachelor's Degree and 2+ years of experience in a cGMP environment Knowledge of standard processes involved in document control and experience in an FDA regulated environment Experience in Aseptic Processing a plus Precise attention to detail Excellent record keeping skills Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems Familiar with Quality Systems and records management in a cGMP environment. Strong communication and problem-solving skills Results oriented with dedication to compliance and customer service Strong initiative and follow-through Comfortable working in a fast paced and dynamic environment. Ability to gown and work in a classified area as required. Work Environment / Physical Demands: Must be able to sit and stand for extended periods Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development. Why Capricor?Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that's changing lives-help us shape the future of healthcare. Come work with us! At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description About Capricor Therapeutics 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 skilled Formulation Scientist to join Capricor Therapeutics and drive the development of stable, lyophilized exosome-based formulations for our groundbreaking therapies. In this critical scientific role, you will lead formulation design, optimization, and characterization, ensuring compliance with cGMP and supporting IND-enabling studies. You will collaborate with cross-functional teams, including analytical sciences, process development, and regulatory affairs, to advance our novel exosome-based drug delivery platforms. This role offers a unique opportunity to shape the future of exosome therapeutics, contributing directly to Capricor's mission to transform the biotech industry and improve lives. Responsibilities Strategic Scientific Leadership Develop and execute innovative formulation strategies for exosome-based drug products, aligning with Capricor's mission to deliver transformative therapies for rare diseases, including DMD. Stay ahead of advancements in exosome, lipid nanoparticle (LNP), and lyophilization technologies, implementing cutting-edge solutions to maintain a competitive edge. Contribute to intellectual property filings and patent strategies, protecting novel formulation technologies and advancing Capricor's scientific leadership. Formulation Development Design and optimize exosome-based formulations for therapeutic modalities (e.g., nucleic acids, proteins, biologics), ensuring stability at 4°ree;C or room temperature for enhanced shelf-life. Lead lyophilization process development for drug substances (DS) and drug products (DP), optimizing excipients, cryoprotectants, and thermal characterization (e.g., DSC, Freeze-Dry Microscopy) to extend stability. Develop storage buffers (e.g., LNP-based) to support flexible storage conditions (4°ree;C, room temperature, -20°ree;C) and improve DS/DP integrity. Conduct forced degradation, real-time, and accelerated stability studies to ensure formulation robustness under non-frozen conditions. Analytical & Quality Control Perform physicochemical and biophysical characterization using techniques such as DLS, TEM, HPLC, LC-MS, DSC, and fluorescence-based assays to assess formulation performance. Develop and validate quality control (QC) methods to evaluate stability, particle size, encapsulation efficiency, and biological activity of exosome-based DS/DP. Ensure compliance with cGMP, 21 CFR Part 1271, cGTP, and ICH guidelines, maintaining rigorous quality standards for injectable formulations. Collaboration & Cross-Functional Support Collaborate with analytical scientists, process engineers, and regulatory affairs teams to define critical quality attributes (CQAs) and support IND submissions. Partner with process development to transition formulations from R&D to clinical and commercial scale, ensuring scalability and GMP compliance. Support technical transfer to contract manufacturing organizations (CMOs), optimizing manufacturing processes for clinical production. Innovation & Optimization Drive advanced formulation optimization to enhance exosome stability and delivery, leveraging data-driven approaches to meet regulatory and clinical demands. Monitor and analyze key performance indicators (KPIs) for formulation processes, implementing corrective actions to improve efficiency and reliability. Stay current with scientific literature and industry trends, contributing to Capricor's innovation in exosome-based therapeutics. Requirements Minimum Qualifications Education: Ph.D. in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemical Engineering, or a related field with 4+ years of biopharmaceutical industry experience; Master's degree with 6+ years of relevant industry experience considered. Experience: 4+ years of hands-on experience in biologics or vesicle-based formulation (e.g., exosomes, LNPs, liposomes, mAbs, peptides) in the biopharmaceutical industry. Lyophilization Expertise: Direct experience with lyophilization process development, including excipient selection, thermal characterization, and cycle optimization for DS/DP stability. Stability Optimization: Proven expertise in optimizing formulation stability at 4°ree;C or room temperature through forced degradation, real-time, and accelerated stability studies. Analytical Skills: Proficiency in analytical techniques, including HPLC, LC-MS, DLS, TEM, and DSC, for formulation characterization. Scientific Leadership: Demonstrated ability to plan and lead initiatives as a hands-on bench scientist in a fast-paced research environment. Regulatory Knowledge: Strong understanding of cGMP, ICH guidelines, and compliance with 21 CFR Part 1271 and cGTP for injectable formulations. Skills: Exceptional problem-solving, attention to detail, and communication skills, with a collaborative approach to cross-functional teamwork. Authorization: Authorization to work in the U.S. without sponsorship. Preferred Skills Direct experience with exosome-based therapeutics or vesicle-based systems (e.g., LNPs, liposomes). 5+ years of industry experience in biopharmaceutical or regulated environments within GMP or QC settings. Expertise in GMP manufacturing, scale-up, and technical transfer to CMOs. Experience authoring CMC sections for IND submissions or supporting regulatory interactions. Proficiency in data analysis tools (e.g., Microsoft Excel, statistical software) and familiarity with process monitoring techniques. Strong scientific communication and technical writing skills for reports, publications, and patent filings. Location Policy This position is based in San Diego, CA, with flexibility for occasional remote work as needed. Work Environment/Physical Demands Physical Requirements: Ability to sit and stand for extended periods, lift/carry laboratory equipment and materials up to 40 pounds, move about the lab, and communicate effectively via telephone or in person. Flexibility: Willingness to work extended or off hours, including weekends and holidays, as required to meet company needs and ensure research continuity. Come Work With Us! Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that's transforming the biotech industry through exosome-based therapeutics, we'd love to hear from you!

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. The Project Management Associate provides coordination and operational support for Quality initiatives at Capricor. This role focuses on project planning, tracking, and cross-functional alignment in a dynamic, fast-paced environment. Responsibilities include maintaining project plans, supporting the development and use of project management tools, and ensuring clear communication and follow-up on Quality deliverables. Ideal for an early-career professional who is organized, adaptable, and eager to grow project management skills within a rapidly evolving biotech organization.Responsibilities Project Planning Support: Support the development and maintenance of project plans, timelines, and task trackers for Quality initiatives at Capricor. Cross-Functional Coordination: Assist with coordinating cross-functional activities across Quality, Regulatory, Manufacturing, Clinical, and other internal teams. Task and Milestone Tracking: Track project tasks, milestones, and action items; follow up with team members to support timely completion. Risk and Issue Awareness: Help identify project risks, dependencies, and potential scheduling conflicts, escalating issues to the Project Manager as appropriate. Project Management Tools: Support the creation, implementation, and maintenance of project management tools, templates, dashboards, and documentation. Status Reporting and Communication: Prepare routine project status updates, meeting agendas, presentations, and summary materials for Quality leadership and stakeholders. Meeting Coordination and Documentation: Attend and support project meetings, document decisions and action items, and distribute meeting notes. Continuous Improvement Support: Assist with continuous improvement efforts by supporting the development of best practices and standard processes within Quality Business Operations. Quality Deliverables Monitoring: Support monitoring of Quality goals, commitments, and deliverables across multiple concurrent projects. Requirements Bachelor's degree with up to 2 years of experience in project coordination, project management, operations, or a related field; experience in biotech, life sciences, or regulated environments is a plus. Strong organizational skills with attention to detail and accurate documentation practices. Proficiency in MS Word, PowerPoint, and Excel; familiarity with project management or collaboration tools (e.g., Smartsheet, SharePoint) is preferred. Clear written and verbal communication skills with the ability to work effectively across cross-functional teams. Ability to manage multiple tasks and shifting priorities in a fast-paced environment. Willingness to learn, take direction, and grow within a project management function. Strong follow-through, accountability, and problem-solving skills. Results-oriented mindset with interest in Quality systems, compliance, and process improvement. Comfortable working in a collaborative, cross-functional team setting. Work Environment and Physical Requirements Professional office setting with a hybrid work model (remote and onsite), with expectation of being onsite at least 1 day per week. Occasional travel may be required. Ability to sit and use a computer for extended periods. Occasional lifting of materials up to 20 pounds. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. We are seeking a Research Associate to support analytical development, formulation work, and laboratory execution for Capricor's StealthX™ exosome platform. This is a hands‑on bench research role, responsible for experimental execution, data generation, documentation, and supporting analytical capabilities critical to platform growth. This position directly contributes to building out our analytical toolbox and ensuring high‑quality data that enables research progression and program decision‑making.Responsibilities Design experiments in collaboration with the supervising scientist to support StealthX™ program objectives. Perform laboratory research, including in vitro assays, buffer preparation, formulation‑related activities, and analytical workflows. Conduct literature reviews to stay current with emerging findings in exosome/extracellular vesicle biology. Maintain accurate electronic lab notebook (ELN) records; ensure data integrity and confidentiality. Summarize and present experimental data to team members and supervisors. Provide timely access to raw and processed data for RPD stakeholders. Request, track, and manage laboratory supplies, reagents, and consumables. Monitor inventory of project‑specific materials and reagents. Prepare progress updates, internal reports, and presentation materials as needed. Attend project meetings, team discussions, and relevant scientific seminars. Work independently and collaboratively in a fast‑paced, goal‑driven R&D environment. Perform additional research‑related duties as assigned. Basic Qualifications Bachelor's degree in Biology, Chemistry, Biochemistry, or related discipline. 1+ years of hands‑on research experience in an academic or industry laboratory. Experience preparing buffers for formulation development. Demonstrated ability to multi‑task, prioritize, and manage deadlines. Strong organizational, communication, and documentation skills. Ability to thrive in a dynamic, fast‑moving research environment. Preferred Qualifications Experience with mammalian cell culture. Experience with assay development or characterization of cell‑based nanoparticles (e.g., exosomes, extracellular vesicles, eVLPs, AAV). Experience with flow cytometry, DNA/RNA/protein functional assays, or related analytics. Hands‑on experience with HPLC sample preparation, routine maintenance, or analytical chromatography. Working knowledge of bioprocessing techniques, including TFF or chromatographic workflows. Experience implementing Design of Experiments (DoE) studies. Work Environment & Physical Requirements Onsite laboratory environment. Prolonged periods of bench work, instrument operation, and computer‑based documentation. Ability to lift items up to 20 pounds. Occasional participation in meetings or cross‑functional discussions. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. The Director of Biostatistics will lead statistical strategy and execution across clinical development programs, ensuring robust study design, analysis, and interpretation to support regulatory submissions and business objectives. This role provides expert guidance on statistical methodologies, oversees internal and outsourced biostatistical activities, and partners cross-functionally to deliver high-quality, compliant analyses. The Director will represent Biostatistics in regulatory interactions, contribute to clinical protocols and analysis plans, and drive innovation in statistical standards and processes. This position requires strong leadership, technical expertise, and the ability to manage complex projects in a fast-paced environment.Responsibilities Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence. Support is the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups. Functions as the lead statistician for assigned clinical projects. Performs management of in-house and/or outsourced biostatistical activities. May engage with regulatory authorities on compound/indication level discussions. Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed. Create programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data. Prepare the statistical section of clinical trial reports and presentations of the results to the team. Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development. Presenting interim trial data to Data Monitoring Committees (DMCs). Writing statistical reports and memos with minimal guidance. Programming complex datasets. Leading or supporting complex analyses, including efficacy and futility interim analyses for DMCs. Supports the preparation and documentation of statistical analyses to enable management to write and support trial reports and publications. Helps ensure that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency. Reviewing statements of work, proposals, and budgets. Managing multiple projects and a majority of own workload. Perform such other duties as may be assigned from time to time. Requirements Master's Degree in statistics, biostatistics or a closely related field; PhD preferred 7+ years clinical trials experience Experience with rare disease and NDA/BLA submission preferred Strong knowledge of statistical software packages including SAS and other applications such as R, and SQL Strong knowledge of therapeutic area and acute care/hospital trial settings preferred Demonstrates strong leadership and management skills Ability to write and articulate clearly Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives Ability to prioritize workload to meet multiple project timelines Excellent planning and organization skills Excellent problem-solving abilities Ability to function independently and exercise judgment and decision-making skills Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. We are seeking an Accounts Payable Specialist in our San Diego offices. This role is responsible for end-to-end accounts payable processing, ensuring accurate, timely and compliant payment of vendor invoices while maintaining strong internal controls. The ideal candidate is detail-oriented, proactive, and thrives in a dynamic, high-growth environment.Responsibilities Processing of high-volume vendor invoices with accuracy. Perform 2-way and 3-way matching. Reconcile vendor statements and resolve discrepancies, short payments, and billing issues. Maintain vendor data including onboarding, updates, and compliance documentation. Respond to internal and external inquiries regarding invoice and payment status. Support month-end close activities. Ensure adherence to company policies and SOX controls. Assist with audits by providing supporting documentation. Identify process improvement opportunities to enhance efficiency and accuracy. Required Qualifications Bachelor's degree in finance or a related field. Experience in biotechnology preferred but not required. Minimum of 2 years of Accounts Payable experience. Experience performing 2-way and 3-way invoice matching. Strong vendor reconciliation experience. NetSuite experience (required). Strong Excel Skills (VLOOKUP/XLOOKUP, pivot tables). Excellent attention to detail and organizational skills. Ability to manage priorities and meet deadlines. Strong written and verbal communication skills. Why Join Us Be a part of a fast-growing biotechnology organization driving innovation and scientific development. Opportunity to make a meaningful impact while helping scale finance operations. Join a collaborative high performing finance team. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor 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 an MSAT Training Specialist at Capricor, you will play a pivotal role in ensuring operational excellence and GMP compliance across our cell therapy manufacturing processes. This position focuses on designing and delivering robust training programs, mentoring manufacturing personnel, and maintaining documentation that supports regulatory readiness and high-quality production. Ideal candidates thrive in a dynamic biotech environment, combining technical expertise with a commitment to continuous improvement and team development.Responsibilities Develop and deliver training on GMP cell culture, cell counting, and aseptic techniques. Collaborate with subject matter experts to identify training needs and align with regulatory best practices. Mentor manufacturing personnel to foster professional growth and GMP adherence. Maintain and update SOPs, batch records, and technical documentation. Support investigations through root cause analysis, impact assessments, and CAPAs. Organize and maintain training lab, including supplies and equipment setup. Partner with QA and Manufacturing for seamless workflow integration. Support Manufacturing Operations inside an ISO7 cleanroom, including performing aseptic operations, process verification, and providing hands-on training. Requirements Bachelor's degree in life sciences or equivalent experience. 1-3 years in a GMP environment, preferably in cell culture manufacturing. Strong knowledge of aseptic techniques, cell counting, and GMP production. Excellent communication, presentation, and organizational skills. Ability to work independently and collaboratively in a dynamic setting. Proficiency in documentation systems and MS Office. Work Environment & Physical Demands 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. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. The Quality Control Analytical Scientist will be a key contributor to Capricor's mission of delivering innovative cell and regenerative therapies, ensuring the highest standards of product quality at our San Diego facility. This lab-based role is critical in advancing our quality control framework by optimizing and validating analytical methods, facilitating seamless technology transfers, and driving continuous improvement initiatives. The scientist will work closely with cross-functional teams to support the development and commercialization of novel therapies, including cell-based products and exosomes, while ensuring compliance with stringent regulatory standards. This position offers a unique opportunity to shape phase-appropriate QC strategies, implement cutting-edge technologies, and directly impact patient outcomes through robust quality assurance.📝 Responsibilities Optimize and troubleshoot QC methods to enhance performance, consistency, and efficiency. Support method qualification, validation, and lifecycle management per regulatory expectations (ICH, USP, FDA). Perform data trending and analysis to monitor assay performance and detect method variability or drift. Collaborate with Analytical Development for seamless method transfers and onboarding of new assays into the QC laboratory. Draft and review method SOPs, validation protocols/reports, and technical documentation. Contribute to investigations, CAPAs, and continuous improvement initiatives within the QC function. Evaluate and implement new technologies or instrumentation to improve assay robustness and throughput. Provide technical documentation and SME input for regulatory inspections and audits. Participate in risk assessments, gap analyses, and change control activities related to QC methods. Train QC analysts on new or optimized assays to ensure consistent and compliant execution. Author and review technical reports, method development summaries, and QC method lifecycle documents. Maintain GMP documentation and laboratory practices with a strong lab-based presence. 🔬 Requirements Ph.D. in a relevant Biological Science discipline. 2-5 years of experience in a GMP Quality Control laboratory or GMP/GLP setting. Hands-on experience with laboratory methods including flow cytometry, Real-Time PCR, DNA isolation, ELISA, bioactivity assays, and next generation sequencing. Knowledge of FDA regulations, ICH guidelines, USP standards, and cGMP requirements for cell therapy or biologics. Proven expertise in method qualification and validation. Ability to independently perform laboratory analysis, troubleshoot, and improve methods. Demonstrated history of successful, independent laboratory work. Excellent communication skills and ability to collaborate effectively in a team environment. 👩 🔬 Work Environment / Physical Demands Must be able to sit or stand for extended periods, move around the facility, communicate effectively, and lift/carry up to 40 lbs. Ability to gown and work in a classified area as required. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor 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. We are seeking a Quality Engineer Associate 3 to lead equipment and facilities CQV (Commissioning, Qualification, and Validation) activities and drive continuous improvement initiatives for Capricor's GMP facility in San Diego. This senior-level role ensures compliance with internal procedures and regulatory guidelines while providing technical leadership in risk management, vendor qualification, and audit readiness. You will serve as a key resource for greenfield and brownfield facility projects, guiding quality engineering strategies that support operational excellence and regulatory compliance.Responsibilities Lead CQV activities for equipment and facilities in alignment with Capricor procedures and regulatory standards. Author and approve validation protocols, reports, and related documentation. Collaborate with Manufacturing, Facilities, Safety, and Quality teams to maintain compliance and operational efficiency. Drive process improvements and implement best practices across quality systems. Review calibration, preventive maintenance, and service reports for GMP equipment and facilities. Provide technical assessments and evaluations within the change control process. Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees. Oversee vendor qualification and compliance audits; prepare technical and investigation reports as needed. Support internal and external audits, including regulatory inspections. Track and report key quality metrics to inform continuous improvement initiatives. Lead quality-related projects and mentor junior team members. Perform additional duties as required. Requirements Bachelor's degree in a scientific or engineering discipline and 3+ years of experience in a pharmaceutical or FDA-regulated environment. Minimum of 3 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product). Strong knowledge of CQV principles and quality systems. Experience leading greenfield or brownfield facility buildouts preferred. Familiarity with regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8-Q10). Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt. Proficiency in Microsoft Word, Excel, PowerPoint, and related applications. Excellent written and verbal communication skills. Ability to work independently and collaborate effectively with technical teams. Work Environment and Physical Demands Professional GMP facility environment. Ability to sit or stand for extended periods. Occasional lifting of materials up to 40 pounds. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. We are seeking an experienced EQMS Business Analyst with specialized expertise in Veeva Vault, preferably someone who has led or played a key role in full Vault implementations (QualityDocs, QMS, Training, and other Vault Quality modules). The ideal candidate will bridge business needs with system capabilities, ensuring that our Veeva ecosystem supports compliant, efficient, and scalable quality operations.Responsibilities: Lead or support end-to-end implementation of Veeva Vault Quality Suite, including requirements gathering, configuration, testing, validation, and go-live activities. Translate business needs into functional specifications and system design within Veeva Vault. Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles. Conduct detailed process mapping of current-state and future-state EQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training). Facilitate workshops with cross-functional stakeholders to define requirements and align system capabilities with business objectives. Identify opportunities for process improvements and automation within Veeva. Support or lead system validation activities including user requirements (URS), functional specifications, IQ/OQ/PQ, and change control in compliance with GxP and 21 CFR Part 11. Ensure adherence to internal quality standards, regulatory expectations, and IT/CSV methodologies. Testing & Deployment Develop and execute test scripts, manage defects, and facilitate UAT sessions. Support go-live planning, cutover activities, and hypercare. Maintain updates to Veeva releases, including impact assessments and regression testing. Training & Support Develop user training materials and deliver hands-on training for business end users. Provide ongoing support, troubleshoot issues, and manage enhancement requests. Serve as a subject matter expert (SME) for Veeva Vault within the Quality organization. Requirements: 3-7+ years of experience as a Business Analyst within Life Sciences Quality (Pharma, Biotech, Medical Devices). Hands-on experience with full Veeva Vault implementation, preferably within the Vault Quality Suite (QualityDocs, QMS, Training). Strong understanding of GxP, 21 CFR Part 11, Annex 11, and industry quality processes. Experience with system validation (CSV) and creating validation documentation. Excellent communication skills with the ability to translate technical concepts to non-technical users. Strong analytical, problem-solving, and stakeholder management skills. Preferred Qualifications: Veeva Vault Administrator or Vault Quality certification(s). Experience working with global teams and regulated environments. Familiarity with integration tools, APIs, and downstream/upstream system interfaces. Experience in managing enhancements post-implementation and supporting continuous improvement. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting AgenciesCapricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. The Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements. This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.Responsibilities Post-Market Surveillance & Data Analysis Manage the end-to-end product quality complaint process from intake through closure. Assess complaints for product quality impact, GMP compliance risk, and field action triggers. Trend and analyze post-market quality data to identify recurring or systemic issues. Integrate post-market data into Product Lifecycle Management (PLM), APQR/PQRs, Management Review, and Quality Metrics/KPIs. Complaint Handling & Investigations Provide Quality oversight of vendors supporting complaint intake or triage. Ensure accurate, complete, and timely complaint documentation. Perform initial Quality assessments and ensure appropriate complaint classification. Escalate potential adverse events to Pharmacovigilance per established procedures. Lead or oversee risk-based investigations that identify root cause, assess scope and recurrence, and are supported by objective evidence and manufacturing history. Quality Risk Management & Field Actions Escalate critical or high-risk quality issues in a timely manner. Identify and assess potential recalls, market withdrawals, or corrections. Lead quality-driven recalls, including regulatory notifications, documentation, and effectiveness checks. Maintain recall readiness through procedures, training, and periodic exercises. CAPA, Quality Systems & Compliance Drive CAPAs resulting from post-market quality issues and verify effectiveness. Maintain and improve SOPs related to complaints, post-market monitoring, recalls, and vendor oversight. Ensure compliance with FDA regulations and internal Quality System requirements. Audit & Inspection Support Oversee Internal Audit program and Inspection Readiness. Act as a Quality SME during FDA inspections and audits. Support preparation of inspection responses and supporting documentation related to post-market quality activities. Requirements Education: Bachelor's degree in Life Sciences, Engineering, or a related field (Master's preferred). Professional Experience: Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment. Leadership: 2 years of people management experience. SME Knowledge: Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions. External Oversight: Experience overseeing external vendors in a regulated Quality environment. Regulatory Foundation: Strong knowledge of FDA Quality System and post-market requirements. Technical Skills: Proven investigation, CAPA, and inspection-readiness experience. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

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. We are seeking a Science to join our Pre-Clinical team to support the progression of our therapeutic programs through the design, execution, and optimization of in vivo research activities and preclinical studies. This role requires deep expertise in in vivo methodologies, strong technical skills, and the ability to perform complex operations in a regulated environment.Responsibilities Partner with the Principal Scientist and Director to provide preclinical expertise, including animal handling and study design. Plan, execute, and analyze in vivo and ex vivo studies to support program objectives. Perform cell-based assays and tissue analyses from in vivo studies; compile and report results. Conduct survival surgeries and establish rodent models using aseptic techniques. Develop, characterize, and implement new animal models to enhance pharmacology study effectiveness. Maintain detailed, audit-ready documentation of all studies to ensure data integrity and traceability. Optimize and implement best practices for in vivo research, including model selection, dosing strategies, and sample/data collection techniques. Ensure compliance with regulatory guidelines and ethical standards for all preclinical activities. Evaluate and integrate new technologies and platforms to improve study efficiency and quality. Perform and interpret preclinical imaging studies (e.g., IVIS). Contribute to a team culture that promotes continuous improvement, ownership, and inclusion. Requirements Ph.D. in a relevant scientific discipline with expertise in nonclinical operations within drug discovery and development. Hands-on experience with cell biology techniques, including RNA/DNA extraction, PCR, Western blot, ELISA, and interventional assays for small molecules and biologics. Preferred Qualifications Experience across diverse therapeutic modalities (small molecules, biologics, nucleic acid therapeutics, gene therapy). Familiarity with age-related disease models (inflammation, metabolic disorders, neurodegeneration, muscle atrophy, bone/joint deficits). Experience with metabolic chambers, behavioral assays, and related data analysis. Work Environment and Physical Demands On-site laboratory environment with routine handling of animals and biological samples. Prolonged periods of standing and performing surgical or technical procedures. Ability to lift laboratory materials up to 20 pounds. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor 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. 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 or biologics manufacturing 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. Responsibilities Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments. Management of deviations and other quality records, performing root cause investigations (6M, 5-Why's, etc) to determine causal factors and evaluate product impact. Training on the cell therapy and/or exosome platforms quickly to assist in product impact assessments, and compiling scientific data relating to the manufacturing processes. Assisting with tech transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines. Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use. Assisting on revising (as needed) and reviewing process-related manufacturing documentation (batch records, SOPs, bills of material, process flow diagrams) to assure all clinical products meet the requirements for quality, safety and efficacy. Providing in-person and real-time manufacturing production support as needed. Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances. Identifying continuous improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in cross functional collaborations. Working closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations. Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset. Performing such other duties as may be assigned to you from time to time. Requirements Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience. A minimum of 1 year experience in adherent cell culture. Additional experience with cells in suspension is a plus. Experience with writing/revising technical documents is required (SOPs, Forms, Batch Records, etc). Previous experience with, or knowledge/understanding of, various quality events is required (Deviations, CAPAs, Change Controls etc). Deep understanding of cell culture and ability to troubleshoot common processing issues. Experience with scale-up of cell therapy processes and closed manufacturing systems preferred. Ability to collect and assist in the analyzation/trending of data and information to determine paths for process improvement and potential root cause. Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles and collaboration with others. Must have 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, as well as work on larger cross-department projects as a team. Work Environment & Physical Demands 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. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor 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 Associate I/II, you'll be a vital part of Capricor's efforts in delivering therapies for patients in need. Supporting critical clinical trials and exosome development, you'll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You'll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor's therapeutic success. Responsibilities Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing. Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols. Mentor fellow team members on cGMP documentation protocols to ensure the highest standards. Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations. Author, revise, and maintain SOPs through Capricor's document change system. Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations. Prepare technical summaries, protocols, and reports to ensure full documentation of production activities. Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance. Take on special projects in manufacturing and development as required. Requirements Bachelor's degree in Biomedical Engineering, Biological Sciences, or a related field. 1-3 years of experience in a cGMP/cGTP manufacturing environment. Solid laboratory experience in mammalian tissue culture, along with expertise in aseptic techniques. Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries. Strong organizational skills and acute attention to detail within a fast-paced, dynamic setting. Basic molecular biology and flow cytometry skills are a plus. Adaptability to work schedules that may include weekends or holidays as needed. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.