Manager, Manufacturing

Location: Houston, TX (Onsite)
Department: Manufacturing
Reports to: Associate Director, Manufacturing 

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

• Manage multiple Cell Therapy or Viral Vector projects simultaneously while successfully coordinating across multiple functional groups to ensure deadlines are met. 
• Prepare and deliver reports and data to internal or external parties.
• Subject Matter Expert regarding Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Incubators, Cell Stacks, Cobes, or Lovos.
• Draft and revise a training program to ensure GMP compliance and operational compliance with cell therapy processes.    
• Draft, revise, and implement high level Standard Operating Procedures to govern the use of GMP facilities.
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices. 
• Perform employee scheduling for multiple simultaneous processes in terms of communication and training standards to work towards a zero-deviation environment.  
• Provide support on IND filings when needed.
• Works with Department Head to establish, drive and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals. 
• Conduct thorough investigations in case of deviations on process excursions in close coordination with all relevant functions.
• Other duties as assigned. 

Qualifications/Skills

• Bachelor's degree in a scientific field; or equivalent combination of education and experience.
• 9+ yr.'s experience in a related manufacturing environment (cell therapy or biotech).
• 3+ yr.'s previous experience in management or supervisory role.
• Previous experience with TIL therapies in manufacturing preferred.
• Strong knowledge of GMP Practices and FDA requirements required.
• Proficient with manufacturing calculations and conversions.
• Previous experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges preferred. 
• Previous experience with a QMS system, such as Veeva, TrackWise, or Master Control required.
• Previous experience with preparation and delivery of reports/data to internal or external parties.
• Able to lead and grow an organization of 10+ personnel.
• Previous experience with developing employees, giving employee reviews, etc.
  • Previous experience authoring and revising SOPs and batch records required.
  • Strong organizational and time management skills. 
  • Proficient with Microsoft Office: Word, Excel, and Outlook.
  • Previous experience with technical writing required.
  • Able to understand and follow personnel flows, cleaning procedures, gowning requirements and other procedures defining requirements necessary to ensure cGMP compliant operations of cleanroom facilities. 
  • Able to troubleshoot cell processing operations and equipment.
  • Meticulous attention to detail in terms of documentation, following procedure SOPs, and performing functions as it pertains to the Batch Record.
  • Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.

 Working Conditions, Equipment, Physical Demands 

The incumbent in this position works in an office and clean room environment. The incumbent in this position will use the following equipment and shall have the following physical demands: 

Equipment-

• Computer
• Printer
• Facsimile
• Telephone
• Manufacturing equipment

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.