Capricor Therapeutics, Inc.

QA Engineer

• Perform QA review of donor screening documentation for donor-derived starting materials, including donor medical history, behavioral risk assessment, and recovery documentation.
• Review infectious disease testing results and laboratory reports to ensure compliance with regulatory donor eligibility requirements.
• Verify completion and accuracy of donor eligibility records including required testing, screening, and documentation.
• Assess hemodilution evaluations, where applicable, to ensure validity and reliability of donor infectious disease testing results.
• Ensure donor records meet applicable regulatory requirements under 21 CFR 1271 Subpart C and internal procedures.
• Document donor suitability determinations and ensure proper QA approval prior to use of donor-derived materials in manufacturing.
• Ensure donor eligibility determinations are completed prior to acceptance and use of donor-derived starting materials for manufacturing.
• Ensure donor eligibility records are complete, traceable, and maintained in accordance with regulatory and internal record retention requirements.
• Ensure donor screening and eligibility review documentation is handled in accordance with HIPAA privacy requirements and company procedures governing the protection of protected health information (PHI).
• Perform QA review of GMP manufacturing batch records for completeness, accuracy, and compliance prior to product disposition.
• Support QA oversight of manufacturing operations, including review of manufacturing documentation and logbooks.
• Review deviations, investigations, and CAPAs for adequacy, root cause determination, and regulatory compliance.
• Participate in change control assessments to evaluate potential quality and regulatory impact.
• Support review and approval of SOPs, protocols, reports, and controlled quality documents.
• Ensure compliance with ALCOA+ data integrity principles across GMP documentation.
• Support internal audits, regulatory inspections, and quality system audits.
• Ensure documentation practices meet GMP and regulatory expectations.
• Identify compliance risks and escalate quality concerns as appropriate.
• Assist in implementation of quality improvements and corrective actions.
• Partner with Manufacturing, Quality Control, Clinical Operations, and Regulatory Affairs to ensure donor eligibility and manufacturing processes are compliant and well controlled.
• Provide QA guidance on donor eligibility requirements and applicable regulatory expectations.
• Participate in cross-functional meetings related to donor material qualification and use.
• Perform rapid yet thorough review of donor information and make eligibility determinations in a timely manner, typically within approximately 20 minutes of receipt of complete donor screening and testing information, to support time-critical acceptance decisions.
• Determine donor suitability based on review of screening documentation and regulatory requirements.
• This position performs and documents donor eligibility and suitability determinations, independently or in coordination with another qualified QA reviewer, that directly affect the qualification and release of donor-derived starting materials for manufacturing.
• Escalate complex or unclear donor eligibility determinations to QA management or the Medical Director as required.
• Apply sound, risk-based judgment in situations where donor information may be incomplete, unclear, or require interpretation.

Quality Assurance Associate II/III – Donor Eligibility, Suitability

Director

• Develop and execute medical affairs strategies aligned with company goals, including evidence generation, scientific exchange, and medical input into cross-functional teams.
• Build and maintain strong relationships with HCPs, KOLs, and patient advocacy organizations in DMD, Becker muscular dystrophy (BMD), and related fields through local, national, and international meetings, 1:1 site visits, and advisory boards.
• Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement, ensuring adherence to regulatory guidelines (e.g., FDA, ICH).
• Create and refine the clinical scientific and value story for deramiocel through internal consultations, external expert input, and data analysis to support program progression.
• Lead scientific communications, including publications, congress presentations, and medical information responses, while overseeing vendors as needed.
• Provide medical expertise to support commercialization readiness activities, including training, payer interactions, and real-world evidence initiatives.
• Work cross-functionally with clinical development, regulatory affairs, commercial, and quality teams to drive business impact and team success.
• Identify opportunities for continuous improvement in medical affairs operations, fostering a culture of innovation and compliance.
• Monitor emerging scientific data, competitive landscape, and therapeutic trends in neurology, myology, cardiology, and rare diseases to inform strategy.
• Perform such other duties as may be assigned from time to time.

Senior Director, Medical Affairs – MD Required

Accountant

• Prepare and review journal entries, account reconciliations, and month-end close activities
• Reconcile complex investment accounts and bank statements to ensure accurate financial reporting
• Oversee prepaid expense tracking, amortization schedules, and related reconciliations
• Manage fixed asset accounting, including capitalization, depreciation, disposals, rollforwards, and reporting.
• Monitor and reconcile construction-in-progress (CIP) accounts, ensuring timely and accurate capitalization of completed projects
• Partner with FP&A, Operations, and Project Management teams to review project spending, validate CIP balances, and ensure appropriate capitalization of costs
• Lead enhancements and process improvements related to fixed asset accounting and reporting
• Assist with property tax filings and other compliance-related reporting requirements
• Assist with internal and external audits by preparing schedules and providing supporting documentation
• Ensure compliance with internal controls, accounting policies, and U.S. GAAP
• Collaborate cross-functionally to support operational and financial initiatives
• Identify and implement process improvements to enhance efficiency, scalability, and accuracy

Senior Accountant

• 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.

Director of Biostatistics

• Support GCP compliance for clinical operations to ensure regulatory adherence.
• Assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity.

Quality Assurance Associate II/III – Donor Eligibility, Suitability

Senior Director, Medical Affairs – MD Required

Senior Accountant

Director of Biostatistics

Clinical Quality Assurance – GCP Specialist