[Hiring] Executive Director, Manufacturing @Secretome Therapeutics

Role Description

Serve as the Chief Technical Officer's operational deputy for Manufacturing and CMC execution, advancing Secretome's clinical and pipeline programs. This highly visible leadership role carries broad responsibility across:

• GMP manufacturing
• Technology transfer
• Process scale-up
• CDMO management
• Master cell banks
• Drug product
• Clinical supply
• Manufacturing readiness
• Operational risk

Qualifications

• 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, with 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.

Requirements

• Advanced degree such as an M.S., Ph.D., or MBA.
• Experience with allogeneic cell, stem/stromal cell, extracellular vesicle, exosome, or secretome-based therapeutics.
• Experience supporting later-stage clinical development or commercial-readiness activities.
• Experience building internal manufacturing capabilities while managing an outsourced network in a small biotech.