· Accountable for desired factory results by providing visible leadership for the company's and factory's purpose, mission, and values through our total performance management (TPM) strategy, which includes goal alignment, employee involvement, root cause/countermeasure analysis, and loss reduction. A minimum of 5 years of this experience must be in prior plant management or operations management of a complex operation that included multiple lines, high speed/high volume production and a continuous improvement mindset. div class="content">Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The individual will provide scientific leadership for assay control strategies, oversee analytical lifecycle activities for control materials, and collaborate with Quality Control, Analytical Development, Process Development, Manufacturing, and Quality teams to ensure robust analytical readiness across Capricor’s therapeutic programs. div class="content">Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. 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 (... div class="content">Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. As part of the QC Raw Materials team, you will perform hands‑on laboratory work, maintain accurate and compliant documentation, support investigations, and collaborate with QC, QA, Procurement, and Manufacturing teams to ensure timely material readiness. p>Duties/Responsibilities: Perform and verse GMP testing of raw materials, including but not limited to identity, sterility, endotoxin, bioburden, mycoplasma, pH, osmolality, and compendial testing Execute material qualification activities for new vendors, materials, and alternate suppliers Review and approve raw material test results and disposition materials in accordance with internal procedures Ensure timely testing and release to support manufacturing schedules Author, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controls Maintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systems Support internal, external, and regulatory audits (FDA, EMA, etc.) Act as a subject matter expert (SME) for raw material testing methods and regulatory expectations Troubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) results Lead or support method transfers, verifications, and validations for raw material assays Evaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreements Identify opportunities to improve testing efficiency, data integrity, and compliance Support implementation of new technologies, methods, and systems Participate in cross-functional teams with QA, Manufacturing, Materials Management and Product Development Coordinate sample shipments for contract testing labs for quality control. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.
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