Executive Director, Manufacturing

This is a fully remote position, open to applicants in Texas.

📋 Description

• Act as the operational deputy to the Chief Technical Officer for Manufacturing and CMC execution, propelling Secretome's clinical and pipeline initiatives forward.

• Deliver daily executive leadership for manufacturing and CMC operations, converting CMC strategy into actionable plans, timelines, budgets, milestones, and risk mitigation strategies.

• Oversee GMP manufacturing from master cell bank to drug product, including testing, release, storage, and clinical supply management.

• Manage CDMOs, contract testing laboratories, key suppliers, and logistics partners through governance, performance metrics, and accountability for quality, timelines, and contractual obligations.

• Facilitate technology transfers, engineering runs, readiness assessments, and scale-up with Process Development and Analytical Development to enhance robustness, scalability, yield, and manufacturability.

• Collaborate with Quality and Regulatory teams on deviations, investigations, CAPAs, change controls, validation, lot disposition, and CMC sections of INDs, amendments, and regulatory submissions.

• Guarantee dependable clinical supply through planning that aligns manufacturing with clinical demand, managing released inventory, cold-chain storage and distribution, chain of custody and identity, as well as contingency plans.

• Cultivate the manufacturing organization by recruiting, developing, and mentoring talent; establishing accountability and decision-making authority; and overseeing budgets, forecasts, and vendor commitments.

⛳️ Requirements

• A Bachelor's degree in biochemical engineering, chemical engineering, bioengineering, biotechnology, cell biology, biochemistry, life sciences, or a related field.

• Around 15+ years of progressive experience in biopharmaceutical manufacturing, technical operations, MSAT, process development, CMC, or related areas.

• Extensive leadership experience with increasing responsibilities for personnel, programs, budgets, and decision-making.

• Direct experience in cell therapy, regenerative medicine, biologics, or other complex biological modalities.

• Strong understanding of GMP manufacturing and phase-appropriate CMC requirements.

• Proven success in leading technology transfer, GMP production, testing, release, deviations, change control, CAPA, and validation processes.

• Significant experience managing CDMOs and contract testing laboratories, including technical oversight, governance, scheduling, budgeting, and quality interfaces.

• Experience supporting INDs, CMC amendments, regulatory responses, or other submissions in the development stage.

• Excellent executive communication, judgment, negotiation, problem-solving, and risk management capabilities.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Flexible work schedule and opportunities for remote work.

• Professional development and continuing education support.

• Generous vacation and paid time off policies.