Hybrid Process Engineer presso CTMC

Location: Houston, TX
Department: Technical Operations

Reports to: Chief Technical Officer
 

About CTMC

 CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.   

Since inception in May 2022, our team has filed eight INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.   

Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals.   

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission. 

Responsibilities

As a Process Engineer, you will provide technical oversight of process equipment and will work with process development and manufacturing during the full equipment life cycle. You will be accountable for technical aspects of quality direct impact systems and critical components used in production, testing, packaging, labeling, and storing of manufactured products to maintain the reliable supply for products across the site. 

• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles. 
• Identify process knowledge gaps that impact equipment and process capability. 
• Support, develop and maintain the basis of safety for process equipment.
• Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose.
• Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment.
• Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control.
• Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.
• Lead/support the tech transfer of new equipment and unit operations across process development and manufacturing 
• Provide technical oversight of ongoing equipment qualification requirements. 
• Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose. 
• Provide guidance in development of test plans for Verification packages and associated critical components. 
• Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. 
• Assist in client audits when required.
• Assist and support routine maintenance activities, if required.  
• Work cross functionally among Process Development, Manufacturing, Quality Control, Quality Assurance, IT and other departments as assigned. 
• Meet and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals. 
• Other duties as assigned. 

 Qualifications/Skills 

• Bachelor’s degree in Engineering.
• 7+ yr.’s experience in related role, preferably in the biotech industry or equivalent combination of education and experience.
• 4+ yr.’s experience in a regulated manufacturing environment.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Experience in Process Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.   
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.  
• Demonstrated strong communication skills, interpersonal skills and a superior drive for results. 
• Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff. 
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.  
• Previous experience with audits preferred.
• Meticulous attention to detail in terms of documentation and following SOPs. 
• Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.

Working Conditions, Equipment, Physical Demands 

Physical Demands-  

• Frequent standing, walking, sitting, and reaching required.
• Frequent lifting up to 10 lbs. required.
• Occasional lifting, pushing, and pulling up to 50 lbs. required.
• Frequent use of computer/keyboard required.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. 

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.