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, 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.