Senior Director, Manufacturing Operations

Immatics•Houston, TX
•Onsite

About The Position

The Senior Director, Manufacturing Operations provides strategic and operational leadership for GMP manufacturing and manufacturing sciences activities supporting late-stage clinical development, regulatory approval, commercial launch readiness, and routine commercial supply of cell and gene therapy products. The role translates CMC strategy into integrated execution across Manufacturing, MSAT, Technical Training, Recipe/Document Development, and Digital Manufacturing Systems.

Requirements

  • Bachelors in a relevant discipline such as Immunology, Biochemistry, Cell Biology, Biotechnology, Bioengineering, or Pharmaceutical Sciences.
  • 15+ years of progressive Technical Operations or Manufacturing Operations experience including 5+ years direct management in cell therapy manufacturing leadership and strategy in industry setting.

Nice To Haves

  • Masters or Ph.D in a relevant discipline such as Immunology, Biochemistry, Cell Biology, Biotechnology, Bioengineering, or Pharmaceutical Sciences.
  • Proven leadership experience supporting late-stage development through commercial manufacturing, including process validation, regulatory submissions, inspection readiness, commercial launch readiness, and ongoing manufacturing operations.
  • Deep expertise in cGMP manufacturing, quality systems, and global regulatory requirements for biologics, cell and gene therapy, or other advanced therapy products.
  • Demonstrated success leading manufacturing investigations, technology transfers, process validation programs, and cross-functional decision-making to drive compliance, operational excellence, and business objectives.
  • Hands-on, visible leader with a strong player-coach mindset. Actively engages with manufacturing operations through routine Gemba presence, team coaching, barrier removal, and rapid resolution of operational, technical, and quality challenges.
  • Experience scaling an internal commercial manufacturing organization.
  • Experience with MES, ERP, LIMS, statistical process monitoring, Lean Six Sigma, and S&OP.

Responsibilities

  • Lead, develop, and mentor a high-performing GMP Operations organization, fostering a culture of accountability, collaboration, and continuous improvement.
  • Translate corporate and Technical Operations objectives into integrated operating plans, resource strategies, and measurable performance goals.
  • Build organizational capabilities, develop future leaders, and drive employee engagement across the function.
  • Partner cross-functionally to align priorities, manage risks, and ensure execution against business objectives.
  • Provide strategic oversight of GMP manufacturing operations, ensuring operational readiness across facilities, personnel, equipment, materials, systems, and processes.
  • Drive safe, compliant, and reliable manufacturing performance through operational excellence, right-first-time execution, and continuous improvement initiatives.
  • Lead commercial manufacturing readiness, product launch activities, capacity planning, and transition to routine commercial supply.
  • Partner with Supply Chain, Quality, Commercial, Clinical Operations, and Patient Operations to establish scalable end-to-end manufacturing and supply processes.
  • Oversee process validation, lifecycle management, process monitoring, and control strategies to ensure a state of continued compliance and operational performance.
  • Lead technology transfer, MSAT activities, technical investigations, process improvements, and post-approval changes.
  • Drive digital manufacturing initiatives, including MES/eBR, automation, manufacturing systems, and data-driven decision making.
  • Ensure alignment between manufacturing operations, regulatory commitments, and GMP requirements.
  • Lead inspection readiness activities and support regulatory inspections, audits, and health authority interactions.
  • Partner closely with Quality and Regulatory Affairs to proactively manage compliance, operational risks, and remediation activities.
  • Establish operational governance through KPI management, performance reviews, risk assessments, and cross-functional decision-making forums.
  • Own operating budgets, headcount planning, capital forecasts, and resource prioritization.
  • Drive cross-functional risk management across quality, supply, capacity, technology, regulatory, and business continuity areas.

Benefits

  • Competitive rates for Health, Dental, and Vision Insurance.
  • 4 weeks of vacation, granted up front each year and prorated for first and last year of employment.
  • 12 company paid holidays.
  • 7 days of sick time.
  • 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars.
  • 100% employer-paid short- and long-Term disability coverage.
  • 401(k) with immediate eligibility and company match.
  • Partially paid parental leave for eligible employees.
  • Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.
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