Director, CMC-GMP

Join Immatics and shape the future of cancer immunotherapy; one patient at a time!  

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.  

 Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology. 

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. 

We are seeking a Director of CMC - GMP to support the Chemistry, Manufacturing, and Controls (CMC) and GMP operations for our adoptive cell therapy programs. This position will oversee internal manufacturing and GMP strategy across late-stage development through potential commercial launch. The ideal candidate has deep technical expertise in cell therapy manufacturing, regulatory acumen, and proven leadership in GMP environments.  

FLSA Classification: Salaried, Exempt  
Schedule: 8:00 AM – 4:30 PM; Monday to Friday; On-site preferred, Remote optional  
Reports to: Vice President, CMC - GMP  
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477  

What You’ll Do: 

As a Director of CMC - GMP, you will play a key role in supporting our Chemistry, Manufacturing, and Controls (CMC) and GMP operations:  

Managerial and Leadership Functions:  

• Act as a role model for team members with respect to earning their trust by your own attendance, keeping your word, personal behaviors, transparent/frank communication, and execution of personal assignments.   

• Hire team members that will fit the job, company culture and team dynamics.  

• Organize and manage team members’ time/schedules and assignments, keep track that team members are utilizing their time in meaningful assignments that will move the company forward.  

• Communicate frequently and regularly with team members assuring they have the information and tools to perform their functions.  

• Resolve conflict between team members if any arises – be an active listener of your team members.   

• Set goals, measure achievement progress, and assist team members in successful execution of their / team goals as well as coach and help develop team members into higher roles at Immatics if they so desire.   

• Provide regular, meaningful (honest but emphatic) performance feedback, expertise, and coaching (5:1 positive to negative ratio) that will help team members grow and develop.  

• Turn feedback into coaching moments and show your willingness to be a partner in team members’ career development at Immatics.   

• Reward and give credit to team members when they deserve – publicly and privately.   

• At the same time, coach team members on the spot if corrections are needed (privately). Provide psychological safety to team members if they make mistakes but expect mistake corrections and improvements.   

• Hold yourself and the team accountable towards company values, mission, and goals.  

• Provide effective oversight to the process development team for day-to-day operations focused on process optimizations for GMP implementations according to aligned CMC strategy for TCR-T products.  

GMP Functions:  

• Provide technical oversight, leadership, and functional accountability of in-house ACT GMP manufacturing operations, including production planning, scheduling, deviation management, and batch record review. 

• Serve as the CMC lead for Regulatory interactions (e.g. FDA, PEI, etc.), including authoring and reviewing CMC sections of INDs/BLAs/MAAs. 

• Collaborate closely with QA, QC, Supply Chain, and Regulatory Affairs to ensure end-to-end GMP compliance and readiness for BLA submission and commercial launch. 

• Lead and guide late-stage manufacturing and BLA preparation activities including but not limited to risk assessments, process validation, and pFMEA analysis ensuring that the final process meets regulatory requirements and quality standards.   

• Drive continuous improvement and tech transfer strategies to support late-stage optimization and commercial scalability of autologous cell therapies. 

• Monitor industry trends, regulatory expectations, and evolving standards related to cell therapy manufacturing and incorporate best practices. 

• Experience in establishing and/or scaling internal GMP manufacturing operations. 

• Prior involvement in late-stage clinical development, BLA readiness, and commercial manufacturing operations. 

• Familiarity with automation technologies and closed-system manufacturing for cell therapies. 

• Spearhead continuous process improvement initiatives by identifying and evaluating opportunities to improve manufacturing outcomes such as improving manufacturing success rate, reducing cost, processing time/resources and maintaining product quality.   

• Oversee successful technology transfer activities, review technical and scientific documents such as study plans and research reports, SOPs, and process transfer protocols and coordinate activities to support successful manufacturing with internal and external partners as applicable.  

• Contribute effectively to CMC strategy for ACT programs enabling decision-making while considering impact to timeline, FTEs/budget, and risks.  

• Contribute to the design of comparability plans and support execution of activities to incorporate process, methods, equipment, facility, and other changes.  

 Secondary Functions:  

• Participate in defining departmental goals and strategic planning to align activities and resources towards achieving those goals.  

• Hire, mentor, and lead a high-performing team to support GMP operations and CMC development goals. 

• Foster and promote collaboration across Process Development, Analytical Development/Operations, Quality, Regulatory, and Clinical teams to ensure seamless execution.  

• Effectively interface with other departments/functions and external parties.  

• Facilitate mitigation and/or escalation of risks identified throughout the product lifecycle as appropriate. 

• Effectively and frequently present data and conclusions to colleagues, collaborators, and senior leadership with the ability to provide meaningful input.  

• Ability to effectively convey messages upwards and downwards from senior management to team with emphasis on impact and criticality. Able to effectively prioritize tasks based on importance and delegate necessary tasks while maintaining the prioritization and urgency to direct reports. 

Required Experience and Education: 

• Masters or Ph.D. in a relevant discipline (Immunology, Biochemistry, Cell biology, Biotechnology, etc.)  

• Twelve (12) + years of cell therapy manufacturing leadership and strategy experience in industry setting, including experience with late stage assets and BLA exposure. 

• Deep understanding of FDA, EMA, and ICH guidelines for biologics and/or cel therapy development. Experience with IND and BLA submissions.  

• Ability to fulfill managerial roles and responsibilities including providing timely feedback.   

• Solid understanding of the fundamentals of QbD and other industry guidelines supporting process development, transfer, qualification/validation, and lifecycle management.  

• Experience in authoring regulatory submissions as well as an understanding of up-to-date regulatory requirements and trends related to cell therapy process development.   

• Adaptable to fast-pace and rapidly changing environment.   

• Ability to organize tasks and prioritize to fulfill needs for different projects running in parallel.  

• Ability to troubleshoot complex manufacturing investigations combining technical, compliance, and business considerations working with cross-functional teams. 

Preferred Experience and Education:  

• Direct supervisory experience and excellent leadership leading large teams. 

• Proven ability to build, lead, manage and motivate high performing teams. 

• Strong technical foundation in biologics or cell/gene therapy manufacturing process and technology.  

Competencies:  

• Excellent communication and interpersonal skills.   

• Proactive execution of daily tasks without the need for micro-management, reminders, and daily input from the manager.   

• Collaboration and engagement in department growth.  

• Friendly and collaborative work approach while achieving daily goals.   

• Detail oriented and accuracy in daily work execution.  

• Excellent organizational skills.   

• High proven technical and/or business competence and significant experience in process development.   

• Result- and solution-oriented rather than problem-painting.   

• Ability to deliver department/function and company objectives.   

• Ability to coordinate the development and implementation of performance goals for a department/function.   

• Ability to lead and execute self-sustainably with minimal oversight.   

• Demonstrate skillful communication internally and externally, delivering impactful information and context concisely.   

• Potential to inspire other team members from own and other functional lines.   

• Understanding of industry trends and leading methodologies. 

• Exceptional expertise and working knowledge of cGMP guidelines and knowledge of Quality System that meets global regulatory expectations.   

• Ability to effectively communicate complex technical content to a range of audiences in oral and written formats.  

• Ability to focus on short term delivery while keeping overall vision and the long-term goals in mind.  

• Strong interpersonal skills and ability to work with others in a positive, collaborative manner  

• High level of self-awareness and emotional intelligence  

Work Environment:  

• Typical office environment with moderate noise levels (~90% of work hours).  

• Uses phone, computer, office equipment and supplies on a regular basis.    

• cGMP clean room spaces and facilities (~10% of work hours).  

• Grade A/B/C/D GMP environment with associated facility noise levels.  

• Uses cleanroom phone, computer, variety of equipment and reagent/supplies.  

• General unclassified laboratory spaces, as needed.  

• Common laboratory equipment and noise levels.  

• While performing the duties of this job, the employee could handle blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide.  

Travel required: Occasionally – may require travelling domestically or internationally for a conference, business meetings, or corporate retreats 

Physical demands: 

• Carrying- to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.   

• Climbing- moving up or down step stools or ladders while maintaining balance  

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.  

• Feeling- the ability to detect different materials or temperatures with fingers and hands.  

• Gowning- sitting or standing to don or remove sterile PPE.  

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.  

• Typing – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.   

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.  

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).   

• Pushing - Exerting force upon an object so that the object moves away from the object.  

• Pulling - Exerting force upon an object so that the object moves toward the force.   

• Reaching- Extending both hands and/or arms perpendicular to the floor and in front of your body towards an object for extended periods of time.  

• Sitting – remaining in a sitting position for at least 50% of the time.  

• Standing/Walking - remain on one's feet in an upright position at a workstation.   

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscle 

Work authorization/security clearance requirements :  

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.   

Affirmative Action/EEO statement:   

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. 

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 Paid Time off, granted up front each year and prorated for first and last year of employment. 

• Sick Time Off – 56 hours  

• 12 Paid Holidays  

• 100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K ( club together) 

• 100% Employer Paid Short- and Long-Term Disability Coverage  

• 401(k) with Immediate Eligibility  & company match… 

• You are eligible for 401(k) plan participation as of your first paycheck. 

• 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. (3 weeks) 

• Additional voluntary employee paid coverages including  Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.  

Professional Growth:  

• Opportunities to work with leading experts in the field of T-cell immunotherapy.  

• Company provided learning and development opportunities 

• Fast paced, high demand collaborative and dynamic environment.