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 oron-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.

• 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.

• 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.

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