About the role
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, and operational risk
What you'll do
- 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 disciplined 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 by connecting manufacturing to clinical demand, with adequate released inventory, cold-chain storage and distribution, chain of custody and identity, and contingency planning.
- Build the manufacturing organization: recruit, develop, and mentor talent, establish clear accountability and decision rights, and manage budgets, forecasts, and vendor commitments.
Qualifications
Required:
- 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.
Preferred:
- 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.
Secretome Therapeutics is a clinical-stage biotechnology company based in Plano, Texas, developing novel therapies derived from neonatal cardiac progenitor cells (nCPC). The Company's lead product candidate, STM-01, is a cellular therapy designed to modulate inflammatory and fibrotic pathways and support myocardial function in Duchenne Muscular Dystrophy (DMD) and Heart Failure with Preserved Ejection Fraction (HFpEF). Secretome is also advancing STM-21, a secretome-based therapeutic currently in preclinical development, and other novel nCPC-based products.