Archives: Job Openings

Location: Houston, TX (Onsite)
Department: Project and Alliance Leadership
Reports to: Head, Project and Alliance Leadership

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

CTMC is looking for a highly motivated Project Leader, with exceptional scientific, drug development, project management and communication skills to support the Project and Alliance Leadership team in Houston, TX. Project & Alliance Leadership (PAL) plays an important role in defining and delivering value to partners within the CTMC mission. PAL serves as a centralized leadership and coordination function that aims to integrate CTMC’s deep cell therapy scientific expertise with an industrial GMP cell therapy manufacturing capability. This position will be responsible for managing execution of cell therapy projects including cross-functional planning and execution, aligning scientific and therapeutic strategy, early phase development, CMC, and regulatory filing to enable accelerated FDA approval and patient access to life saving therapies. This role involves managing multiple cell therapy programs, requiring careful coordination with both external partners and internal stakeholders. Prior project management experience and a strong understanding of CMC and/or drug development is required. This role will report to the Head of Project and Alliance Leadership. 

Responsibilities:

• Directly manage multiple development projects, leading cross-functional teams through strategy, planning and execution of projects at the manufacturing site, and driving these projects to IND filing and first in human clinical trials. 
  • Project leadership will encompass cell therapy programs that are developed in collaboration with MDACC faculty and/or with biotechnology companies.
  • Target expectations would encompass leading at least 2 novel cell therapy projects through IND studies to first-in-human clinical trials over the first 12 months.
  • Working with both internal and partner stakeholders to:
    • Coordinate development activities to assure a high-quality process and assays are ready for Manufacturing and QC on time
    • Oversee the transition from Development into Manufacturing and the execution of supportive engineering runs
    • Coordinate functional groups with Regulatory to generate pre-IND and IND submissions and that regulatory strategies are clearly communicated
  • Coordinate with MD Anderson clinicians to enable a transparent exchange of clinical data
• Prepare and track project scope of work, project plans and budgets. 
• Monitor project progress and ensure execution and accountability within the team.
• Proactively identify project issues, potential risks and delays, and provide strategies for risk mitigation. 
• Clearly and effectively communicate project progress and provide visibility to the project team, functional heads, senior management, and external partners. 
• Contribute to the organizational and project governance structure
• Provide visibility across projects and departments
• Facilitate and support project transitions between external partners and CTMC as well as between CTMC departments (for example from development space into the GMP environment or through IND submission to clinical manufacturing)
• Other duties as required.

Qualifications/Skills:

• Bachelor’s or Master’s degree in engineering, science, or related field required, PhD preferred 
• 12+ years of relevant work experience, including 6 years of project leadership/ management in cell therapy or closely related field (or equivalent combination of education and experience).
• Experience in early to late phase human therapeutic (drug) development and Familiarity with Cell Therapy and/or Biologics development to IND required 
• Experience with Cell Therapy manufacturing highly preferred 
• Mindset focus on strategic thinking, data-driven decision making and effective communication 
• Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint 
• Experience with matrix project management and/ or agile project management is beneficial 
• Experience with digital systems and/ or digital transitions, including programming, is beneficial.
• Experience working in a fast-paced, collaborative team environment
• Possess mindset focus on strategic thinking, data-driven decision making and effective communication
• Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint
• Experience with off the shelf or bespoke scheduling software/ solutions a plus

Working Conditions, Equipment, Physical Demands

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

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times.

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.

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 8 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

• Vendor Management:
  • Assist in managing existing supplier relationships and resolving performance issues.
  • Monitor and report on supplier performance, ensuring compliance with contractual obligations.
• Procurement Process:
  • Receive and process purchase requisitions in a timely manner.
  • Create, manage and track purchase orders to ensure timely delivery and fulfillment.
  • Collaborate with internal stakeholders to clarify specifications and delivery requirements.
• Cost Management:
  • Analyze market trends, supplier pricing and cost data
  • Identify and recommend cost-saving opportunities.
• Documentation and Compliance:
  • Maintain accurate records and up-to-date procurement records and documentation
  • Ensure compliance with internal company policies and regulatory requirements.
  • Prepare reports and analysis on procurement performance. 
• Cross-Functional Support:
  • Partner with the finance team to review invoices and ensure accurate billing.
  • Contribute to researching and resolving issues related to vendor performance.
  • Support the development and implementation of procurement strategies.
  • Collaborate with other departments to facilitate smooth procurement processes.
• Other duties as assigned

Qualifications/Skills

• Bachelor’s degree in business administration, supply chain management, or a related field preferred
• 1+ yrs experience in a related field, preferably procurement or purchasing or equivalent combination of education and experience.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines

Working Conditions, Equipment, Physical Demands The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times.

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.

Location: Houston, TX
Department: Manufacturing
Reports to: Sr. Manager, 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 

• Perform cleaning, kitting, documentation, processing, and materials procurement for the manufacturing department.
• Maintain aseptic technique during processing to ensure quality and integrity of cellular drug products.
• Assist with training staff on proper operations and documentation in cGMP cleanroom facilities. 
• Operate standard cleanroom equipment: Incubators, BSCs, and Centrifuges. 
• Operate the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Incubators, Cell Stacks, Cobes, or Lovos.   
• Provide input to develop SOP’s for new and incoming equipment.
• Provide input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment. 
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
• Execute master batch production records in a timely manner and maintain accurate documentation with FDA’s Good Manufacturing Practices.
• Request and prepare materials for manufacturing operations while maintaining proper inventory levels in the cleanroom at all times.
• Assist support for routine maintenance activities.  
• Ensure transparent communication with staff, teams, support functions, and site leadership team.   
• 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 scientific field or specialized Associate’s cell therapy degree preferred or equivalent education and experience.
• 1+ yr.’s experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required, 2+ yr.’s preferred.
• 1+ yr.’s experience in a related manufacturing environment (cell therapy or biotech) required, 2+ yr.’s preferred.
• Previous experience with the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Cell Stacks, Cobes, or Lovos preferred.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Previous GMP Experience preferred.
• Previous experience performing accurate calculations and lab measurements preferred.
• 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. 
• 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 environment and cleanroom. The incumbent in this position will use the following equipment and shall have the following physical demands:  

 Equipment- 

• Computer, printer, telephone, and cleanroom 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.

Location: Houston, TX
Department: Manufacturing
Reports to: Manager, 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 

• Perform kitting, documentation, processing, and material procurement for the manufacturing department.
• Perform any routine or non-routine cleaning of the clean room areas or equipment when required.
• Maintain aseptic technique during processing to ensure quality and integrity of cellular drug products.
• Assist with training staff on proper operations and documentation in cGMP cleanroom facilities. 
• Operate standard cleanroom equipment: Incubators, BSCs, and Centrifuges. 
• Provide input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment. 
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices. 
• Meticulous attention to detail in terms of documentation, following procedure SOPs, and performing functions as it pertains to the Batch Record. 
• Assist in support for routine maintenance activities.  
• Ensure transparent communication with staff, teams, support functions, and site leadership team.   
• Meets and reports key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals. 
• Other duties as assigned. 

Qualifications/Skills 

• High school diploma or GED required, Bachelor’s degree in scientific field or specialized Associate’s cell therapy degree preferred.
• No experience required with Bachelor’s degree or specialized Associate’s cell therapy degree, 4 yrs. related manufacturing experience with High School Diploma or GED, or equivalent combination of education and experience.
• Previous experience in mammalian cell culture, tissue culture and using aseptic technique preferred.
• Previous experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges preferred. 
• Proficient with Microsoft Office: Word, Excel, Outlook, and Teams.
• 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 learn the basics of Cell Therapy processes.
• Previous experience performing accurate calculations and lab measurements preferred.
• 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.  

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:

We are seeking a highly skilled and detail-oriented Quality Control Specialist III with a strong background in cell-based assays, including molecular techniques and flow cytometry, to support quality testing of cell and viral therapy products. The ideal candidate will have hands-on experience in advanced molecular platforms, aseptic techniques, and cGMP-compliant analytical testing.

• Perform analytical testing on cell and viral therapy products to assess quality, purity, and safety, ensuring compliance with regulatory standards.
• Execute and interpret molecular assays, including Vector Copy Number (VCN), Replication Competent Virus (RCV), and Mycoplasma testing, utilizing PCR-based methodologies.
• Demonstrate hands-on expertise with qPCR and ddPCR technologies, as well as automated DNA extraction platforms.
• Conduct and analyze cell-based assays, with demonstrated proficiency in flow cytometry and associated analytical techniques.
• Support method qualification (MQ) activities, including drafting and reviewing Standard Operating Procedures (SOPs), Forms (FRMs), and protocols.
• Perform aseptic sample processing for analytical testing in accordance with Good Laboratory Practices (GLP).
• Adhere to established laboratory quality control procedures, ensuring accurate and timely documentation of all testing activities per SOPs.
• Perform equipment calibration, preventive maintenance, and maintain equipment logs to support a state of compliance.
• Contribute to the development, revision, and continuous improvement of SOPs related to testing methods, equipment operation, and general laboratory practices.
• Execute daily laboratory tasks to ensure alignment with production and testing schedules.
• Conduct stability testing for cell therapy products and viral supernatants according to established protocols and stability programs.
• Support laboratory investigations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) assessments, with appropriate documentation.
• Assist in the execution of method, equipment, and process validation/qualification activities in compliance with ICH guidelines, cGMP, cGTP, and other applicable regulatory standards.
• Participate in technology transfer activities, including method transfer and associated documentation.
• Support reference standard characterization and contribute to data trending analyses.
• Ensure laboratory readiness for internal audits and external regulatory inspections by maintaining compliance with applicable quality and regulatory standards.
• Assist in inventory management activities to maintain uninterrupted laboratory operations.
• Promote laboratory organization and cleanliness, ensuring adherence to 5S and continuous improvement principles.
• Perform other duties as assigned to support departmental and company objectives.

Qualifications/Skills

• Bachelor’s degree in a scientific discipline, or an equivalent combination of education and relevant experience.
• Minimum of 3 years of experience in analytical testing within a Quality Control (QC) laboratory, including:
  • Molecular assays (e.g., qPCR, ddPCR)
  • Automated and manual cell count and viability assessments
  • Flow cytometry
  • ELISA or other immunoassays
• Demonstrated expertise in at least one key assay category.
• Strong proficiency in performing accurate laboratory calculations and unit conversions.
• Prior experience in drafting or reviewing Standard Operating Procedures (SOPs) is preferred.
• Proven ability to collaborate effectively within cross-functional, multidisciplinary teams.
• Capable of executing planned laboratory activities independently with minimal supervision.
• Self-motivated and proactive in taking on additional responsibilities.
• Preferred: Experience with Laboratory Information Management Systems (LIMS), including configuration or workflow design to support QC operations.
• Proficient in Microsoft Office applications (Excel, Outlook, Word, etc.).
• Willingness and availability to work flexible hours to support time-sensitive testing aligned with manufacturing schedules.
• Able to work effectively in a fast-paced environment and communicate clearly with diverse team members.

Working Conditions, Equipment, Physical Demands

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

Equipment-

• Computer
• Printer
• Scanner
• Telephone
• Lab Equipment

Physical Demands-  

• Frequent sitting, standing, walking
• Carrying packages and moving bins and boxes, lifting up to 10 lbs.

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.

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

• Play an important role in cell therapy cryopreservation process development projects with the goal to implement and improve quality and function of CAR-T, TILs and other cell therapies.  
• Participate in the design, planning and execution of process development experiments aimed at optimizing the cryopreservation, fill and finish of T-cell products for cancer immunotherapy. 
• Develop processes in alignment with regulatory guidelines to ensure rapid translation of developed procedures in the GMP lab. 
• Perform assays to define physical characteristics of the cells important for cryopreservation optimization utilizing specialized equipment such as a cryomicroscope or a cell analyzer
• Assess and optimize cryoprotectant formulations to enhance product survival and performance.
• Take initiative of troubleshooting problems as they arise in the lab and shares best practices and lessons learned with the team. 
• Execute project deliverables to meet timelines. 
• Assist with data analysis and interpretation of experiments to optimize freezing, thawing, and storage conditions for our cell therapies.
• Maintain clear and rigorous experimental records, including electronic laboratory notebooks
• Write protocols and technical reports. 
• Participate in Manufacturing Batch Record drafting and reviewing
• Prepare scientific presentations to report on the status of the work performed in the laboratory and speak in front of a group of scientists and management. 
• Communicate effectively with lab members within the process development team and with stakeholders across different functions such as manufacturing, analytical development, quality assurance and regulatory affairs.  
• Other duties as assigned.

Qualifications/Skills

• Bachelor in a related scientific/engineering field.
• 7+ years’ relevant experience, or Masters degree, preferably in the biotech industry or equivalent combination of education and experience.
• Experience in Process Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.   
• Strong knowledge in cell biology.  
• Experience in cryobiology is a plus.
• Experience with microscopy, equipment temperature mapping, cryopreservation of immune cells in desirable.
• 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.  
• Able to operate with minimal supervision. 
• Proficient with Microsoft Office Suite or related software.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in a laboratory environment as well as an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment-

• Computer, printer, fax, telephone
• Laboratory equipment

Physical Demands-

• Frequent standing and walking required.
• Frequent sitting, reaching, and computer/keyboard usage.
• Occasional lifting, pushing, and pulling up to 20 lbs. required.

This job may also require to operate in a cleanroom environment occasionally. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when 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.

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 assigned CAR-T projects as required, 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: Incubators, Prodigies, Lovos, Cues, etc.
• Draft and revise a training program to ensure GMP compliance and operational compliance with CT processes.    
• Draft, revise, and implement high level Standard Operating Procedures to govern the use of GMP facilities.
• Perform gap analysis programs for new processes and successfully complete Tech Transfers under required deadlines.
• 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.
• Establish, drive and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals in partnership with other departments.
• Conduct thorough investigations in case of deviations on process excursions in close coordination with all relevant functions.
• Train Manufacturing Associates on New Processes.
• Other duties as assigned. 

Qualifications/Skills

• Bachelor’s degree in a scientific field; or equivalent combination of education and experience.
• 7+ yr.’s experience in a related manufacturing environment (viral vector, cell therapy, or biotech), experience with viral vector or TIL processes a plus.
• 1+ yr.’s previous experience in a management or supervisory role.
• Strong knowledge of GMP Practices and FDA requirements required.
• Proficient with manufacturing calculations and conversions.
• Previous experience with a QMS system, such as Veeva, TrackWise, or Master Control required.
• Previous experience with technical writing required.
• Previous experience with preparation and delivery of reports/data to internal or external parties.
• Able to lead, train and grow an organization of 5+ personnel.
• Previous experience with developing employees, giving employee reviews, etc.
• Previous experience authoring and revising SOPs and batch records required.
• Previous experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges preferred. 
• Strong organizational and time management skills. 
• Proficient with Microsoft Office: Word, Excel, and Outlook.
• 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.
• Able to establish new systems or processes to achieve manufacturing goals and reduce workplace error.
• Able to take on ancillary cross-functional projects and drive to completion.
• 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.

Location: Houston, TX
Department: Quality Assurance
Reports to: Head of Quality Assurance

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 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:

• Ensure line-clearance/ change-over activities are executed.
• Oversee the disposition, hold, or rejection of raw materials, starting materials, in-house prepared materials, intermediates, and drug products.
• Ensure the generation and reconciliation of in-process and Drug Product labels is performed with compliance aspects being met.
• Ensure the review and approval of executed documents related to manufacturing operations, QC, and other departments is performed with compliance aspects being met.
• Initiate, author, review and approve deviations, CAPAs and Change Controls associated with Quality Operations practices as well as other departments.
• Create, review, and approve procedures and practices within Quality Operations to implement company quality standards.
• Partner with other departments to implement, optimize, review, and approve batch records, practices, and procedures.
• Accomplish quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
• Develop quality assurance plans by conducting hazard analyses and monitoring procedures.
• Achieve quality assurance operational objectives by contributing to information analysis.
• Validate quality processes by establishing product specifications and quality attributes.
• Maintain and improve product quality by completing product, company, system, and compliance audits.
• Train and motivate employees on Quality Operations procedures and practices to ensure quality standards are met.
• Lead and manage a team of quality professionals, directing them toward achieving goal-oriented tasks.
• Support the recruitment process by assisting in the identification, selection, and hiring of qualified candidates.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in scientific field.
• 12+ yrs. related experience in QA.
• 6+ yrs. managerial experience, preferably within QA.
• Understanding of Cell and Gene Therapies.
• Demonstrate expertise in multiple QA related areas; SME in specific areas related to operations.
• Understanding of cGMPs, GLPs and GXPs.
• Knowledge of local and global regulations.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Proficient with Microsoft Office Suite or related software.

Working Conditions, Equipment, Physical Demands

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

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.

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.

Location: Houston, TX
Department: Manufacturing
Reports to: Head of Technical Operations

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

• Lead, mentor, and develop a team of 20+ manufacturing managers and associates, focusing on driving high performance, fostering employee engagement, and ensuring overall job satisfaction.
• Manage the evaluation, implementation and execution of electronic systems, ensuring seamless integration with existing processes and driving operational efficiency across the team.
• Oversee capacity utilization and modeling for GMP suites, equipment, and personnel, optimizing resources to ensure maximum efficiency and meet production goals.  This includes potentially evolving shift scheduling from the current 5/8+dynamic scheduling to fit-for-purpose models based on forecasted demand.  
• Coordinate with Process Development, Quality Control, Quality Assurance, and Project Leadership to ensure timely completion of all Technical Transfers.
• Drive continuous improvements in all Manufacturing operations, focusing on enhancing quality and safety standards.
• Serve as Manufacturing Lead for audits, inspections, submissions and regulatory requests.
• Ensure timely close out of all deviations, CAPAs, and change controls related to all Manufacturing Processes.
• Maintain a high level of compliance through effective monitoring and reporting of key metrics to CTMC’s Quality Council.
• Develop innovative approaches to improve effectiveness of training program for manufacturing staff to enable rapid onboarding as well as overall operational flexibility through cross-training.
• Promote a culture of continuous improvement, collaboration, and safety, while leading by example to maintain a productive and secure work environment.
• Enhance existing relationships with local organizations (i.e. community colleges) to create a talent pipeline
• Other duties as assigned. 

Qualifications/Skills

• Bachelor’s degree in scientific field, or equivalent education and experience.
• 12+ yrs. experience in a related manufacturing environment (cell therapy or biotech)
• 6+ yrs. experience in management or supervisory role. 
• Preferred- 5+ Yrs Exp in Experience with Cell Therapy, including troubleshooting processing and equipment
• Previous experience with implementation or use of an ERP, LIMs, CMMS, or MES systems
• Strong knowledge of GMP Practices and FDA requirements required.
• Strong organizational skills to efficiently lead an organization of 20+ personnel.
• Previous experience with personnel growth and development plans including periodic and annual reviews. 
• Previous experience in technical authoring, including SOPs, batch records, protocols and technical reports.
• 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 establish new systems or processes to achieve manufacturing goals and reduce workplace error.
• Able to take on ancillary cross-functional projects and drive to completion.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Able to assist and be on call in a flexible schedule including nights, weekends, and holidays.

Working Conditions, Equipment, Physical Demands

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

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.

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.