Why Work Here?

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.

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 Manager with exceptional 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/portfolio. PAL serves as a centralized leadership function that aims to integrate CTMC’s deep technical and scientific expertise with operational capability to help create disruptive manufacturing solutions enabling impactful cell therapies to reach patients. In this role, you’ll be at the nexus of several of CTMC’s mission critical planning and execution work processes.  

 This role involves managing multiple GMP programs, requiring careful coordination with both external partners and internal stakeholders. You will act as the liaison with external partners to oversee the lifecycle of each GMP batch, from collection through disposition. Internally, you will lead the coordination of manufacturing, testing, and release timelines for GMP batches across all programs and modalities (TIL, CAR-T, and VV).

CTMC is continuously transferring technologies from development to operational functions. In this role, you will serve as a work process administrator for Technology Transfer across all programs (manufacturing processes, test methods, etc.) and modalities (TIL, CAR-T, and VV). You will define best practices and support Tech Transfer leads from both sending functions (PD, AD) and receiving functions (MFG, QC), ensuring smooth handovers of critical path activities.

Duties include but are not limited to:

• Assisting with management of multiple programs in GMP production:
  • Serve as external interface with MD Anderson Cancer Center and biotech partners to coordinate starting material collections, provide visibility throughout manufacturing, and help plan finished drug product for disposition 
  • Maintain demand forecasts for all programs and then monitor and provide visibility to actual demand in real-time across GMP operations 
  • Serve as internal coordinator for production planning and scheduling across GMP operational functions including MFG, QC, and QA 
  • Develop and lead production tracking, establishing key metrics and managing partner deliverables to ensure timely and successful outcomes. 
  • Drive development and implementation of key manufacturing digital/information systems that enable better planning, scheduling, execution, and analysis of GMP operations 
• Support project management of programs entering the GMP production phase to:
  • Serve as technology transfer workflow administrator by developing procedures and tools/templates (e.g. PFD, BOM/BOE, MBRs, trackers, etc.) to help standardize the transfer of critical process and analytical knowledge 
  • Support or lead the digitalization of test methods and manufacturing batch records through the implementation of an LIMS/MES and expanding its functionality 
  • Support technical (sending) and operational (receiving) leads during tech transfers by facilitating communication, coordination and the adoption of best practices and tools.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in life science, or related field required
• 7+ yr.’s. of relevant work experience, 1+ years of experience in cell therapy, production planning or closely related field or equivalent combination of education and experience preferred
• Experience in academic and/or industrial cell therapy manufacturing or biologics manufacturing, preferred
• Experience in early to late phase human therapeutic (drug) development 
• Experience with both technical development and operations of advanced cell and gene therapies 
• Experience interfacing with clinical site stakeholders 
• Experience in cross-functional leadership roles 
• 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

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 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

• Able to understand and follow personnel flow, cleaning procedures, gowning requirements, and other protocols essential for maintaining cGMP-compliant operations within cleanroom facilities.
• Perform routine or non-routine 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.
• Provide support for routine maintenance activities, such as performing a daily, weekly, or monthly cleaning of the clean rooms when required.
• 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 equivalent education and experience.
• Min. 0-1 yrs experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required, 2+ yr.’s preferred.
• Min. 0-1 yrs 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. 
• Demonstrates meticulous attention to detail in documentation, adhering to SOPs, and performing tasks related 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: Project and Alliance Leadership
Reports to: Director, 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 Coordinator with exceptional 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/portfolio. PAL serves as a centralized leadership function that aims to integrate CTMC’s deep technical and scientific expertise with operational capability to help create disruptive manufacturing solutions enabling impactful cell therapies to reach patients. This position will be assisting with the execution of cell therapy projects including cross-functional planning and execution, early phase development, CMC, and regulatory filing to enable FDA approval and patient access to life saving therapies. Prior project management experience and understanding of CMC and drug development is preferred. This role will report to the Director, Project and Alliance Leadership.

Duties include but are not limited to:

• Facilitate project administration across cross functional teams:
  • Support coordination ensuring effective communication across the various functional teams, including viral vector and cell therapy process development
  • Assist with project timelines, deliverables, and resource management to ensure successful project execution.
• Administrative support of project meetings with internal and external stakeholders:
  • Provide support in scheduling, preparing agendas, distributing meeting materials, documenting meeting minutes, and tracking action items to ensure follow-through.
• Assist in coordination of development activities to assure a high-quality process and assays are ready for GMP manufacturing and product release
• Assist with oversight of the transition from process development into GMP manufacturing and the execution of supportive engineering runs
  • Collaborate with cross-functional teams to ensure a seamless transition
  • Provide support to help identify and escalate challenges to minimize delays
  • Facilitate communication between stakeholders to ensure alignment on project status
• Assisting with preparation and tracking of gap analyses, support scoping of prospective work, project plans and budgets
• Supporting communications with internal and external stakeholders
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in life science, or related field required
• 3+ yr.’s. of relevant work experience, 1+ years of project coordination in cell therapy or closely related field or equivalent combination of education and experience preferred
• Previous experience with biologics manufacturing preferred
• 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
• Candidates must be able to work onsite at our Houston, TX office.

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

The Quality Control (QC) Specialist I is responsible for conducting environmental monitoring (EM) and safety testing to support aseptic production and final drug product release. This role ensures compliance with Good Manufacturing Practices (GMP) and regulatory standards, contributing to the overall quality and integrity of the manufactured products.

• Perform routine environmental monitoring of air, surfaces, and personnel, including sampling using contact plates, viable and non-viable particulate sampling in classified aseptic production areas.
• Analyze collected samples for microbial contamination, or other relevant parameters. Interpret data and document findings in accordance with company procedures and regulatory requirements.
• Manage data entry, reporting and review of EM data within an electronic EM system.
•  Perform microbial identification of isolated organisms.
• Execute media fill simulation in aseptic environments.
• Ensure timely receipt and submission of samples within the organization.
• Support the qualification of cleanroom facilities and assist with annual shutdown and restart programs. 
• Perform sterility testing, endotoxin analysis, Gram staining, and basic biochemical testing.
• Execute growth promotion and pH testing for microbiological media.
• Conduct stability testing as per protocols for cell therapy and viral supernatant products.
• Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines. 
• Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations. 
• Perform basic maintenance, calibration, and quality control of laboratory equipment.
• Maintain inventory and order laboratory supplies as needed. 
• Other duties as required. 

Qualifications/Skills

• Bachelor’s degree in Biological Sciences, Biotechnology or a related field required.
• 1+ yr.’s experience in a quality control laboratory including knowledge of environmental monitoring, microbiological testing, and GMP requirements preferred, 0+ yr.’s required or equivalent combination of education and experience.
• Proven capability to work aseptically in cleanroom environments.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Able to carry out planned laboratory activities with minimal supervision.
• Shows initiative to take on additional responsibility.
• Proficient with Microsoft Office (Excel, Outlook, etc.).
• Able to work flexible work hours to maintain critical testing during manufacturing runs.
• Capable of working in a fast-paced environment and communicating effectively with a diverse work group.

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.