Why Work Here?

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 six 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, an ambitious biomanufacturing organization that has raised $2 billion in two years, 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 94+ 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 system admin responsibilities for Veeva.
• Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, etc.
• Manage the processing, archival, filing, scanning, indexing, and formatting of new and existing documents within guidance of the document control procedures via the document management system (Veeva Docs).
• Administer and monitor QMS training and perform as a training curriculum admin for site.
• Monitor and support implementation and execution of electronic systems, including assessment of use, needs and areas of improvement.
• Support the partnership of cross-functional departments to ensure alignment of processes, systems and procedures within Veeva, and continuous improvement and user experience within the system.
• Other duties as required.

Qualifications:

• Bachelor’s degree in a scientific field.
• 3+ yrs experience in a related field, preferably QA or equivalent combination of education and experience.
• Understanding of Cell and Gene Therapies.
• Understanding of cGMPs, GLPs and GXPs.
• Verbal and written communication skills.
• Interpersonal and customer service skills.
• Organizational skills and attention to detail.
• Time management skills with a proven ability to meet deadlines.
• General knowledge in implementation and continuous improvement on electronic systems (example, Veeva, LIMS, electronic batch records, etc.) preferred
• Lean Six Sigma Yellow Belt Certification Preferred
• Proficient with Microsoft Office Suite or related software.
• Able to work independently on routine tasks with minimal guidance or oversight.
• Demonstrate initiative to take on additional responsibilities.
• Able to train junior members within the department.

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 six 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, an ambitious biomanufacturing organization that has raised $2 billion in two years, 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 94+ 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 routine and advanced flow cytometry experiments, including sample preparation, data acquisition, and data analysis.
• Analyze flow cytometry data using specialized software and interpret results for both internal and external reports.
• Participate in the development and optimization of new flow cytometry assays.
• Provide technical expertise and training to other laboratory personnel and research teams as needed.
• Support Flow Cytometry methods troubleshooting and investigations.
• Accurately perform, analyze, and demonstrate proficiency on the following tests: Automated and manual cell counts and viability, ELISA, Molecular assays.
• Perform analytical testing on cell and viral therapy products, to verify product quality, purity, and safety. 
• Participate as an analyst in MQ activities including authoring SOPs and FRMs.
• Demonstrate aseptic processing of samples for relevant tests.
• Follow laboratory’s quality control policies and procedures. 
• Document all quality control activities according to SOPs.  
• Perform and document equipment maintenance and calibration activities according to SOPs.  
• Assist in writing new SOPs, and revising SOPs for test methods, equipment maintenance, and general laboratory practices. 
• Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines. 
• Perform stability testing as scheduled and specified in the stability studies or protocol for cell therapy and viral supernatant products. 
• Assist in the execution of validation/qualification programs per ICH guidelines, cGMP and cGTP and other applicable standards. 
• Reference material/standards characterization and trending. 
• Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations. 
• Support inventory management for all QC lab activities. 
• Maintain laboratory upkeep and organization.
• Other duties as required. 

Qualifications/Skills

• Bachelor’s degree in science field required or equivalent combination of education and experience.
• 3+ years of hands-on experience with flow cytometry, preferably in a research or clinical laboratory setting required; 4-5+ years preferred.
• Proficiency in operating flow cytometers (e.g., BD FACSLyric, Novocyte Advanteon, or similar instruments) and associated software (e.g., FlowJo, Kaluza, BD FACSuite).
• Strong background in immunology, cell biology, and/or molecular biology.
• Knowledge of LIMS software/system and previous experience using LIMS for product lot testing, EM and/or stability samples is a plus.
• Excellent analytical skills with a strong attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Experience with accurate laboratory calculations and conversions.
• Previous experience with writing SOPs preferred. 
• 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
• 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 six 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, an ambitious biomanufacturing organization that has raised $2 billion in two years, 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 94+ 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.  

Summary: 

Reporting to the Head of Regulatory Affairs, the Sr. Manager, Regulatory Affairs CMC will be responsible for contributing to CMC strategies as well as coordinating many aspects of CMC regulatory submissions. This person will work closely with the development team, particularly with the Process Development, Analytical Development, Quality Control, Manufacturing, and Quality groups to define and contribute to the CMC strategy in development programs at CTMC. CTMC has a unique, flexible and value-added partnership model with biotech companies and MD Anderson Cancer Center. The role will be a central player in this nexus and ensure clear communication of roles and responsibilities across the partners to enable efficient execution of IND-enabling activities, IND submissions and lifecycle management. 

 Responsibilities

• Supports or leads regulatory CMC strategy development, planning, and implementation for multiple programs at CTMC.
• Participates and contributes on cross-functional internal and joint project teams in providing regulatory CMC guidance throughout the lifecycle of product development.
• Prepare, coordinate, author, review, and maintain CMC content in regulatory submissions (e.g., IND, DMF, amendments, annual reports, meeting packages) within target timelines.
• Identify risk areas and develop alternative courses of action including anticipation of regulator responses and development of contingency plans in concert with technical functions.
• Prepare technical assessments of CMC source documentation and responses to client technical questions on document content.
• Review/approve change controls related to proposed product/process changes and assessing their impact on specific regulatory requirements.
• Maintain knowledge of CMC regulations/guidelines and apply appropriately to projects.
• Involved in preparation and supports CMC interactions with regulatory health authorities.
• For assigned submissions, responsible for all aspects of publishing submissions and/or submission components and for transmitting to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, transmission, and archiving, as applicable.
• Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs or other departments.
• Other duties as required.              

Qualifications:

• Bachelor’s degree in chemistry, Biology, Chemical Engineering or related field required, advanced degree preferred.
• 12+ yr.’s relevant experience, including 6+ years regulatory affairs CMC or related experience within the cell and gene therapy industry or equivalent combination of education and experience.
• Strong understanding of cell and gene therapy development, manufacturing and controls, and analytical testing.
• Demonstrated knowledge of US regulations related to CMC and cell and gene therapy product development.
• Strong writing skills and attention to detail with ability to deliver high quality regulatory documents.
• Strong organizational/project management skills in order to maintain a high level of communication, productivity, innovation, and priority-setting in order to work effectively in a dynamic environment to meet aggressive timelines.
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within and outside the company.
• Strong computer skills including MS Word, Excel, PowerPoint, and Adobe Acrobat.

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

​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.