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 seeking a highly motivated and technically proficient person to support the implementation and ongoing configuration of the L7 LIMS platform within our GMP-regulated Quality Control (QC) laboratories. This role is critical to the digital transformation of analytical operations supporting cell and gene therapy manufacturing. The ideal candidate will possess a strong blend of technical expertise in scripting languages and a good understanding of regulated QC laboratory processes.

Key Responsibilities:
• Collaborate with internal stakeholders to gather user requirements and translate them into functional digital workflows within the L7 LIMS platform.
• Support design and implementation of assay-specific workflows, including configuration of sample lifecycle, metadata capture, testing specifications, result entry interfaces, and final result logic.
• Develop custom formulas and statistical logic for automated result calculation, trending, and pass/fail evaluation.
• Build reusable workflow components, including templates and calculation engines, that support standardization and data integrity across QC operations.
• Support configuration of QC test methods within the LIMS, integrating unit management, acceptance criteria, control charting, and other analytical attributes.
• Write and implement custom code (e.g., JavaScript, Python, or other supported scripting languages) to enhance or automate LIMS functionality per user and system requirements.
• Support validation and documentation efforts in accordance with 21 CFR Part 11, Annex 11, and applicable GAMP guidance.
• Participate in LIMS user training, troubleshooting, and change control processes.
• Other duties as required.

Qualifications/Skills
• High School Diploma required; enrollment in a Bachelor’s degree program in a relevant field preferred.
• Hands-on experience with coding and scripting to support LIMS automation and customization is preferred.
• Familiarity with LIMS configuration, assay design, and workflow management.
• Able to work in a fast-paced environment.
• Demonstrated ability to be nimble, collaborative, and eager to contribute.
• Excellent verbal and written communication skills with strong attention to detail.
• Prior involvement in LIMS validation and computer system validation (CSV) documentation is 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, telephone, and laboratory testing equipment

Physical Demands-
• Occasional standing and walking required
• Frequent sitting, reaching, and computer/keyboard usage

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 (The responsibilities listed are specified as but not limited to):

• Issuance of non-clinical, clinical, and ancillary documents needed to support operational areas.
• Perform line-clearance/ change-over activities.
• Perform disposition of raw materials, starting materials and in-house reagents.
• Review and approve executed documents related to Manufacturing, QC, and other departments.
• Participates in initiating SOPs, Forms or quality events associated with Quality Operations practices.
• Participate in QA Shop Floor.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in a scientific field.
• Previous experience in QA preferred or equivalent combination of education and experience.
• 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.
• Analytical and problem-solving 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:

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, and located in the renowned 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, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.  

In our first year alone, we have filed 8 INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience leverages their experience in advanced technology and processes to deliver exceptional results.  

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of industry veterans and 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 mission. 

At CTMC, we value our employees and offer a variety of development opportunities within our organization. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. 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:

CTMC is looking for a highly motivated Specialist III, 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. PAL serves as a centralized leadership and coordination function that aims to integrate CTMC’s deep cell therapy scientific expertise with a powerful GMP operational capability. In this role, you’ll be at the nexus of CTMC’s operational planning and execution workflows.  

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 patient collection through disposition. Internally, you will lead the operational coordination of manufacturing, testing, and release for GMP batches across all programs and modalities (TIL, CAR-T, and VV).

Responsibilities:

• Support GMP operational planning for a portfolio of cell therapy programs
  1. Develop and maintain batch production forecasts based on contractual obligations, strategic intelligence, and other real-time context
  2. Develop and maintain a tactical operational plan based on forecasts, slot modeling, scheduling rules, resource allocations, and other constraints
• Support GMP operational execution for a portfolio of cell therapy programs
  1. Support external interface with MD Anderson Cancer Center and biotech partners to coordinate patient starting material collections, provide visibility throughout manufacturing, and help plan finished drug product for shipment and disposition 
  2. Support the work-process to manage capacity by ensuring efficient resource utilization and continually reconciling a tactical board of active slots, lots, and requests
  3. Serve as internal coordinator for scheduling across GMP operational functions including MFG, QC, and QA 
• Support GMP project value realization and business intelligence
  1. Develop insights on operational performance by maintaining production and resource tracking tools and providing reports to program and functional leadership
  2. Drive development and implementation of key digital/information systems that enable better planning, scheduling, execution, and analysis of GMP operations 
  3. Support reconciliation of actual batch production with internal accruals and external partner invoicing to ensure value realization of our GMP operations
• 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 experience in cell therapy, production planning, master scheduling, or closely related field or equivalent combination of education and experience preferred
• Experience in academic and/or industrial cell therapy manufacturing or biologics manufacturing, highly preferred
• Experience in early to late phase human therapeutic (drug) development 
• 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 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.