Senior Director, Manufacturing Operations

Immatics; Stafford (TX); On-site; USD 250,000 - 320,000; Full time

Benefits offered by this job

Comprehensive Benefits

Health, Dental, Vision Insurance

401(k) with company match

Parental leave

Job summary

Immatics in Stafford, TX is seeking a Senior Director, Manufacturing Operations to provide strategic and operational leadership for GMP manufacturing and MSAT activities supporting late-stage development and commercial supply of cell and gene therapies. The role emphasizes cGMP compliance, tech transfer, process validation, and digital manufacturing initiatives (MES, ERP, LIMS).

You will lead a high-performance team, manage budgets, and partner across Quality, Regulatory, Supply Chain, and

Qualifications

• 15+ years in Technical Operations or Manufacturing Operations
• 5+ years direct management in cell therapy manufacturing leadership
• Deep expertise in cGMP manufacturing, quality systems, and global regulatory requirements
• Experience with process validation programs and tech transfers
• Hands-on leader with team coaching and barrier removal

Responsibilities

• Lead GMP Operations organization and drive accountability
• Translate objectives into operating plans and measurable goals
• Oversee manufacturing readiness across facilities, equipment, and systems
• Drive product launch readiness and capacity planning
• Lead technology transfer, MSAT activities, and investigations
• Ensure compliance and inspection readiness across quality and regulatory

Skills

GMP Operations

Manufacturing Leadership

Cell Therapy

cGMP

Regulatory Submissions

Process Validation

MSAT

Lean Six Sigma

Education

Bachelor’s in Immunology/Biochemistry/Cell Biology

MS/PhD in relevant field

Tools

MES

ERP

LIMS

Job description

***Join Immatics and shape the future of cancer immunotherapy; one patient at a time!***Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of **PRAME**, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest **PRAME** franchise with the most **PRAME** indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. **Why Join Us?*** **Innovative Environment:**Help to pioneer advancements in cancer immunotherapy.* **Collaborative Culture:** Be part of a diverse team dedicated to your professional growth.* **Global Impact:**Contribute to therapies that make a lasting impact on patients globally.**Role Overview**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.**Schedule:** Monday-Friday, 1st Shift with weekends and holidays as needed**Reports to**: Site Head, Immatics US & Vice President, Technical Operations**Location**: Onsite, 13203 Murphy Road Suite 100 Stafford, TX 77477**Basic Qualifications:*** 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.**Preferred Qualifications:*** 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.**In this role you will:****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.**Travel Requirements:*** Occasional; may require travelling domestically or internationally for a conference, business meetings, or corporate retreatsQualified candidates will participate in a structured interview process, which includes:* An initial recruiter phone screen (conducted via video)* Interviews with the hiring leader and other key stakeholders* A final-stage interview**What do we offer?**At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics **Comprehensive 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. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.* 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. **Equal Employment Opportunity** We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law. **Reasonable Accommodations**We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at [e-mail]. **Work Authorization** Applicants must be authorized to work in the United States without the need for current or future sponsorship. **Pre-Employment Requirements** Employment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening, where permitted by applicable law. For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity.