Senior Director, Manufacturing Operations
Immatics
Summary
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.
Job description
Leadership & Organizational Development
- 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.
GMP Manufacturing & Commercial Operations
- 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.
Technical & Process Excellence
- 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.
Compliance
- 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.
Strategic Business Leadership
- 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.
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.
- 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.
Benefits
- Health, Dental & Vision Insurance
- 4 weeks vacation
- 12 paid holidays
- 7 days sick time
- Employer-paid life insurance
- Employer-paid short-term disability
- Employer-paid long-term disability
- 401(k) with company match
- Partially paid parental leave
- Accident insurance
- Hospital indemnity insurance
- Critical illness insurance
- Identity theft protection
- Pet insurance
Company overview
Immatics is a clinical-stage biotechnology company and the global leader in precision targeting of PRAME (Preferentially Expressed Antigen in Melanoma), a cancer target expressed in more than 50 different cancer types. Founded in 2000 as a spin-off from the University of Tübingen's Department of Immunology, the company has grown into a publicly traded entity (NASDAQ: IMTX) with operations in Germany and the United States. Immatics specializes in developing T-cell redirecting immunotherapies, including TCR T-cell therapies and TCR bispecifics, for the treatment of solid tumors. The company's proprietary XPRESIDENT™ technology platform enables the identification of tumor-associated peptides (TUMAPs) with unprecedented sensitivity, allowing for the development of highly specific cancer immunotherapies. With a robust clinical pipeline focused on PRAME-targeting therapies, Immatics is advancing multiple programs including IMA203 (anzutresgene autoleucel) for PRAME-positive solid tumors, IMA402 PRAME bispecific, and IMA401 MAGEA4/8 bispecific. The company's innovative approach combines mass spectrometry, genomics, biochemistry, and immunology to create novel cancer treatments that address significant unmet medical needs in oncology.