Director Process Development

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 8:00 am – 5:00 pm  

Department: CMC-Process & Analytical Development 

Reports to: VP, Process & Analytical Development 

Supervisory responsibilities: Yes 

Location: Remote or preferably on-site at 13203 Murphy Road Suite 100 Stafford, TX 77477 

Position Summary/objective: 

We are seeking a highly motivated, energetic and team-oriented professional with demonstrated expertise in cell therapy process development. The successful candidate will lead a team focused on the development of TCR-T programs for the treatment of solid tumors. The main role of the Director will be to provide scientific, technical and operational leadership to support the development and optimization of a robust commercial manufacturing process for a late-stage cell therapy program. In addition, the successful candidate will contribute to advancements and development of manufacturing processes to support current and future pre-clinical and clinical ACT programs.  

Essential functions: 

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. 

Process Development Functions: 

• Provide leadership, and functional accountability for CMC Process Development group for the ACT projects. 

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

• Develop and implement process control strategy for critical process parameters (CPPs), ensuring optimal process performance and consistent product quality. 

• Leverage own field knowledge and expertise in developing manufacturing processes for current and future cell therapy pipeline based on QbD principles, keeping the requirements of clinical and commercial manufacturing in mind. 

• Drive and support innovation through exploration of technological solutions to advance autologous and allogeneic platforms e.g. process automation, new equipment, systems and software to improve workflows and efficiency. 

• Support GMP manufacturing by sharing insights and providing scientific reasoning to troubleshooting efforts for understanding and solving manufacturing failures.  

• Spearhead continuously 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.  

• Stay abreast with the new developments in the field of cell therapy and maintain a deep understanding of process development strategies and best practices as applied from early development to late stage and commercialization of ACT products. 

• Oversee successful technology transfer activities, review technical and scientific documents such as study plans and research reports, SOPs, process transfer protocols, clinical 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. 

• Collaborate and co-ordinate with and lead/participate in cross-functional teams to facilitate BLA-readiness workstreams and planned regulatory activities. 

• Foster and promote collaboration across Process development, Analytical development, Analytical operations, GMP manufacturing, MSAT, Quality, Regulatory, and Clinical teams to ensure seamless execution. 

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

• Contribute to the establishment of the framework for manufacturing data trending, establishment of process controls. 

• Serve as a solid scientific and technical knowledge base to support regulatory activities including submissions, addressing requests for information, scientific advice, agency meetings. 

Secondary functions: 

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

• Assist in hiring for department and departmental budget preparation as needed. 

• Promote and build compliance to Intellectual Property procedures, submit invention disclosure reports, assist in review and submission of patent applications.  

• Participate in promoting external collaborations related to Process Development.  

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

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

• Participate in due diligence activities related to Immatics new collaborations. 

Qualifications: 

• Ph.D. in a relevant discipline (Immunology, Biochemistry, Cell biology, Biotechnology) with 12+ years relevant experience in industry or academia. 

• Knowledge of bioprocess modeling, data analysis, and automation. Familiar with FMEA, QbD, DoE, and statistical analysis tools (JMP). 

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

• Knowledge of analytical methods (e.g., flow cytometry, ELISA, biological activity or potency of cellular products) to support process development and release testing. 

• Subject matter expertise in cell therapy process development with deep knowledge and hands-on proficiency in process optimizations using standard and advanced cell therapy manufacturing equipment. 

• Sound understanding of T cell biology, molecular and immunological methods used for characterization including flowcytometry. 

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

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

• Understanding of regulatory requirements and trends related to cell therapy manufacturing.  

• 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. 

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

Preferred: 

• Ph.D. in the relevant field and 6+ years of industry experience in late-stage process development of cell therapy drugs is highly desirable.  

• Direct supervisory experience and excellent leadership leading large teams. 

• Knowledge of GMPs and regulatory requirements applicable to cell and gene therapy and BLA authoring experience. 

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 

Travel:  

Occasionally – may require travelling domestically or internationally for a conference or business meetings 

Work environment: 

This is a sedentary position (at least 50% of the time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. The ability to sit, talk, walk, hear and communicate verbally and in writing is required. 

Physical demands: 

• 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. 

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

• Keyboarding – 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.  

• 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 muscles.  

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.” 

Other duties: