We are currently seeking a Full Time Director, CMC Commercial Strategy within IMMATICS’ CMC to support our team. This position will work predominantly in Houston, Texas and reports to VICE PRESIDENT OF CMC. Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.
This position will be responsible for planning, developing and implementing the CMC process for late-stage clinical development and commercial manufacturing strategies for Immatics portfolio of cellular immunotherapy products. Furthermore, this position will be responsible for building a complete supply chain of critical material, manufacturing equipment, management of finished drug products, and logistics associated with their distribution. This position will represent and work within CMC but cross-functionally with various Immatics teams including Quality Control, Quality Assurance, Project Management, Clinical Development, and Clinical Operations on all aspects of drug product distribution and logistics. The position will be responsible for working with external partners and vendors for the procurement of necessary manufacturing material and necessary supply agreements. Finally, the position will be responsible for sourcing and qualifying manufacturing facility solutions along with the CMC leadership and for adaptation of Immatics manufacturing processes to new facilities and necessary technology transfer.
The main responsibilities of this position will include but are not limited to the following tasks:
• Plan, develop, and implement manufacturing strategies and processes for late-stage clinical development and commercial uses for Immatics cellular immunotherapy products.
• Oversee activities related to the selection of facility solutions including Contract Manufacturing Organizations (CMOs), Immatics own internal or partner facilities.
• Oversee the supply chain for procurement of raw material necessary for the manufacturing of Immatics products.
• Develop, implement, and manage master supply agreements with key vendors including critical raw material and viral vectors to supply compliant biological drug substances for the clinical, launch and commercial phases.
• Oversee safe, compliant and efficient operation of area processes, Good Documentation Practices, timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure inspection readiness.
• Oversee technology transfer activities from Immatics CMC to external CMO’s or other manufacturing facilities.
• Responsible for ensuring that Immatics manufacturing facilities are compliant and inspection ready by both US and international regulatory agencies.
• Perform market research and analyze threats and opportunities in manufacturing start-up and growth.
• Establishing operational budgets and forecasting for equipment (CAPEX), material as well as capacity allocation in line with supply plans.
The qualifications for this position include, but are not limited to the following:
• REQUIRED: Master’s or PhD Degree in in Chemical/Biochemical Engineering, Biochemistry or related scientific discipline.
• PREFERRED: Experience working in Lean/Operational Excellence environment with certification in lean tools.
• A minimum 8 years of experience in the cell or gene therapy field and 3 years of experience in with biopharmaceutical late-stage clinical development and/or commercial manufacturing, supply chain logistics, and material management duties.
• Proven background in leading product commercialization in the cell & gene therapy industry.
• Working knowledge in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
• Experience in client and vendor relationship management.
• Exceptional expertise and working knowledge of cGMP guidelines and knowledge of Quality System that meets global regulatory expectations.
• Understanding of industry trends and leading methodologies.
• Experience with process scale up principles and involved tech transfer activities for clinical and commercial production scales is preferred.
• Solid knowledge of regulatory compliance and GMP systems at least in the US in EU.
• Excellent communication and interpersonal skills.
We expect a high degree of independent working, analytical reasoning and excellent communication skills. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured,
reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.
What Immatics Offers
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. Immatics offers partial subsidized health, dental and vision
insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance, and stock options.
If you’re interested in working for Immatics, please forward you CV along with a letter of introduction via e-mail to RecruitingUS@immatics.com. For more detailed information about Immatics and privacy protection visit www.immatics.com.