Chief Manufacturing & CMC Operations Leader

Secretome Therapeutics, Inc.; United States; A distancia; USD 250.000 - 450.000; Jornada completa

Descripción de la vacante

Secretome Therapeutics, Inc. in Plano, TX, seeks a Chief Technical Officer’s operational deputy for Manufacturing and CMC execution to advance clinical and pipeline programs.

This leadership role spans GMP manufacturing, technology transfer, scale-up, CDMOs, master cell banks, drug product, clinical supply, and readiness, with focus on risk management. You will lead day-to-day manufacturing and CMC operations, drive strategies into executable plans, budgets, milestones, and risk mitigations, and

Formación

• Bachelor's degree in biochemical engineering, chemical engineering, bioengineering, biotechnology, cell biology, biochemistry, life sciences, or 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 CMC requirements; experience with tech transfer and validation.

Responsabilidades

• Provide day-to-day executive leadership for manufacturing and CMC operations, translating strategy into executable plans, 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, and suppliers through governance, metrics, and quality interfaces.
• Drive technology transfers, engineering runs, readiness assessments, and scale-up to improve robustness, scalability, yield, and manufacturability.
• Partner with Quality and Regulatory on deviations, investigations, CAPAs, change controls, validation, lot disposition, and IND/CMC regulatory responses.
• Ensure reliable clinical supply by connecting manufacturing to clinical demand, with adequate inventory, cold-chain storage, and distribution controls.
• Build the manufacturing organization: recruit, develop, and mentor talent; manage budgets, forecasts, and vendor commitments.

Conocimientos

Leadership

GMP Manufacturing

CMC

Technology Transfer

CDMO Management

Regulatory Liaison

Budgeting

Risk Management

Educación

Bachelor's degree

MS/PhD/MBA a plus

Descripción del empleo

Secretome Therapeutics, Inc. in Plano, TX, seeks a Chief Technical Officer’s operational deputy for Manufacturing and CMC execution to advance clinical and pipeline programs.

This leadership role spans GMP manufacturing, technology transfer, scale-up, CDMOs, master cell banks, drug product, clinical supply, and readiness, with focus on risk management. You will lead day-to-day manufacturing and CMC operations, drive strategies into executable plans, budgets, milestones, and risk mitigations, and