Job Openings Archive

QC Specialist IV

Location: Houston, TX (Onsite)
Department: Quality Control
Reports to: Supervisor or Manager/Sr. Manager, Quality Control

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

Responsibilities

Perform analytical testing on cell and viral therapy products, to verify product quality, purity, and safety.
Accurately perform, analyze, and demonstrate proficiency on the following tests:
Automated and manual cell counts and viability
Flow cytometry analysis
ELISA
Molecular assays (PCR, ddPCR)
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 documents 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 performing laboratory investigations related to OOS/ OOT/Abnormal analysis.
Assist in the execution of validation/qualification programs per ICH guidelines, cGMP and cGTP and other applicable standards.
Assist with equipment qualification, validation programs and/or performance qualification programs.
Reference material/standards characterization and trending.
Assist with technology transfer activities.
Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations.
Ship and receive materials and samples to support QC testing and release.
Support inventory management for all QC lab activities.
Review and release raw materials to be used in GMP manufacturing.
Maintain laboratory upkeep and organization.
Train junior members of the team on medium-high complexity assays.
Other duties as required.

Qualifications/Skills

Bachelor’s degree in science field required or equivalent combination of education and experience.
5 yr.’s analytical testing in a quality control laboratory including, automated and manual cell counts and viability, flow cytometry analysis, ELISA and molecular assays.
Serve as an SME one or more assay categories.
Experience with accurate laboratory calculations and conversions.
Demonstrated aptitude for managing reports.
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, fax, and telephone.

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.

Manager, Computer & Equipment Validation

Location: Houston, TX (Onsite)

Department: Technical Operations
Reports to: Manager, Equipment

About CTMC

Responsibilities

Lead CTMC’s compliance of 21 CFR 211 regulations for all equipment, including Manufacturing and Quality Control.
Draft or review all validation documents related to CSV including User Requirement Specifications, Design Verifications, Qualification Protocols, and Validation Reports.
Lead the integration, programming and automation of all CTMC’s MES and LIMS systems.
Lead day-to-day, including weekends, operational support and troubleshooting activities involving automated equipment and process control systems.
Assist in client audits when required.
Assist with training staff on MES or LIMS systems.
Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
Assist and support routine maintenance activities, if required.
Work cross functionally among Manufacturing, Quality Control, Quality Assurance, IT and other departments as assigned.
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 Computer Science, Life Sciences, or Engineering.
9+ yr.’s experience in related role.
4+ yr.’s experience in a regulated manufacturing environment.
Experience with IT infrastructure, digital systems, and software solution deployments for biopharmaceutical business operations.
Previous experience with MES and LIMS preferred.
Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
Previous GMP Experience preferred.
Previous experience with audits preferred.
Meticulous attention to detail in terms of documentation and following SOPs.
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, labs, and clean room environments. 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.

Associate Director, Project & Alliance Leadership

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

About CTMC

Responsibilities

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

Responsibilities:

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

Qualifications/Skills:

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

Working Conditions, Equipment, Physical Demands

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

Equipment- Computer, printer, fax, and telephone.

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

Associate II, Procurement

About CTMC

Since inception in May 2022, our team has filed 8 INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.  

Responsibilities

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

Qualifications/Skills

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

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

Equipment- Computer, printer, fax, and telephone.

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

Associate II, Manufacturing

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

About CTMC

Responsibilities

Perform cleaning, kitting, documentation, processing, and materials procurement for the manufacturing department.
Maintain aseptic technique during processing to ensure quality and integrity of cellular drug products.
Assist with training staff on proper operations and documentation in cGMP cleanroom facilities. 
Operate standard cleanroom equipment: Incubators, BSCs, and Centrifuges. 
Operate the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Incubators, Cell Stacks, Cobes, or Lovos.   
Provide input to develop SOP’s for new and incoming equipment.
Provide input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment. 
Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
Execute master batch production records in a timely manner and maintain accurate documentation with FDA’s Good Manufacturing Practices.
Request and prepare materials for manufacturing operations while maintaining proper inventory levels in the cleanroom at all times.
Assist support for routine maintenance activities.  
Ensure transparent communication with staff, teams, support functions, and site leadership team.   
Meet and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals. 
Other duties as assigned.

Qualifications/Skills

Bachelor’s degree in scientific field or specialized Associate’s cell therapy degree preferred or equivalent education and experience.
1+ yr.’s experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required, 2+ yr.’s preferred.
1+ yr.’s experience in a related manufacturing environment (cell therapy or biotech) required, 2+ yr.’s preferred.
Previous experience with the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Cell Stacks, Cobes, or Lovos preferred.
Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
Previous GMP Experience preferred.
Previous experience performing accurate calculations and lab measurements preferred.
Able to understand and follow personnel flows, cleaning procedures, gowning requirements and other procedures defining requirements necessary to ensure cGMP compliant operations of cleanroom facilities. 
Meticulous attention to detail in terms of documentation, following procedure SOPs, and performing functions as it pertains to the Batch Record. 
Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.

Working Conditions, Equipment, Physical Demands

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

Equipment-

Computer, printer, telephone, and cleanroom equipment

Physical Demands-

Frequent standing, walking, sitting, and reaching required.
Frequent lifting up to 10 lbs. required.
Occasional lifting, pushing, and pulling up to 50 lbs. required.
Frequent use of computer/keyboard required.

QC Specialist III

About CTMC

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.

Process Engineer I, Process Development

About CTMC

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.

Associate Director, Quality Assurance Operations

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

About CTMC

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. 

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.