Executive Director, Manufacturing

🕒 Outubro 30

🤠 Texas – Remoto

🤠 Texas – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Secretome Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2018

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

🔥 Investimento no último ano

💰 $30.000.000 Series A em 2026-05

Biotechnology • Healthcare • Pharmaceuticals

A Secretome Therapeutics é uma empresa de biotecnologia que desenvolve terapias regenerativas derivadas de células progenitoras cardíacas neonatais e de seu secretoma. Seus principais programas — STM-01 (terapia celular neonatal) e STM-2 (produto à base de secretoma) — estão sendo desenvolvidos para insuficiência cardíaca com fração de ejeção preservada (HFpEF) e cardiomiopatia dilatada (DCM). A empresa destaca a variabilidade quase nula entre doadores, o maior rendimento e a maior potência obtidos de fontes neonatais em comparação com células-tronco adultas, além de uma fonte celular ética e não fetal, que permite uma fabricação consistente e escalável. A Secretome conduz ensaios clínicos em estágio inicial e comunica uma política de acesso expandido para uso investigacional.

Descrição

• Serve as the Chief Technical Officer's operational deputy for Manufacturing and CMC execution, advancing Secretome's clinical and pipeline programs • Provide day-to-day executive leadership for manufacturing and CMC operations, translating CMC strategy into executable plans, schedules, budgets, milestones, and risk-mitigation strategies • Lead GMP manufacturing from master cell bank through drug product, testing, release, storage, and clinical supply • Lead CDMOs, contract testing laboratories, critical suppliers, and logistics partners through governance, performance metrics, and accountability for quality, schedule, and contractual deliverables • Drive technology transfers, engineering runs, readiness assessments, and scale-up with Process Development and Analytical Development to improve robustness, scalability, yield, and manufacturability • Partner with Quality and Regulatory on deviations, investigations, CAPAs, change controls, validation, lot disposition, and CMC sections of INDs, amendments, and regulatory responses • Ensure reliable clinical supply through manufacturing-to-clinical-demand planning, released inventory, cold-chain storage and distribution, chain of custody and identity, and contingency planning • Build the manufacturing organization by recruiting, developing, and mentoring talent; establishing accountability and decision rights; and managing budgets, forecasts, and vendor commitments

🎯 Requisitos

• Bachelor's degree in biochemical engineering, chemical engineering, bioengineering, biotechnology, cell biology, biochemistry, life sciences, or a related discipline • Approximately 15+ years of progressive experience in biopharmaceutical manufacturing, technical operations, MSAT, process development, CMC, or related functions • Significant leadership experience with increasing responsibility for people, programs, budgets, and decisions • Direct experience with cell therapy, regenerative medicine, biologics, or another complex biological modality • Strong knowledge of GMP manufacturing and phase-appropriate CMC requirements • Demonstrated success leading technology transfer, GMP production, testing, release, deviations, change control, CAPA, and validation • Significant experience managing CDMOs and contract testing laboratories, including technical oversight, governance, schedules, budgets, and quality interfaces • Experience supporting INDs, CMC amendments, regulatory responses, or other development-stage submissions • Strong executive communication, judgment, negotiation, problem-solving, and risk-management skills

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