Executive Director, Manufacturing

🔥 0 minutes ago

🤠 Texas – Remote

infoinfo

⏰ Full Time

🔴 Lead

👔 Director

Where this job comes from

Posted on Secretome Therapeutics's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of Secretome Therapeutics

Secretome Therapeutics

11 - 50 employees

Founded 2018

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $30M Series A on 2026-05

Biotechnology • Healthcare • Pharmaceuticals

Secretome Therapeutics is a biotechnology company developing regenerative therapies derived from neonatal cardiac progenitor cells and their secretome. Their lead programs—STM-01 (neonatal cell therapy) and STM-2 (secretome product)—are being developed for heart failure with preserved ejection fraction (HFpEF) and dilated cardiomyopathy (DCM). The company emphasizes near-zero donor variability, higher yield and potency from neonatal sources compared with adult stem cells, and an ethical, non-fetal cell source to enable consistent, scalable manufacturing. Secretome is conducting early-stage clinical trials and communicates an expanded access policy for investigational use.

📋 Description

• 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

🎯 Requirements

• 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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