Why Work Here?

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 four INDs, each ahead of schedule, 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 state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 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 novel corporate structure. 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:

Reporting to the Head of Regulatory Affairs, the Associate Director, Regulatory Affairs CMC will provide support for the regulatory affairs department with a primary focus on driving cell and gene therapy projects that are developed in collaboration with MD Anderson Cancer Center and with biotechnology companies to IND filing and first-in-human clinical studies. The Associate Director, Regulatory Affairs CMC is responsible for leading and/or supporting regulatory activities supporting multiple projects per year as they progress from preclinical POC to clinical POC including development activities, pre-IND meeting preparation, incorporation of pre-IND meeting feedback into IND-enabling activities, IND preparation and submission, coordination with MD Anderson Cancer Center to enable study activation and ongoing monitoring in coordination with the Clinical Research Office.

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

• Serve as the Regulatory Affairs CMC lead on assigned projects and provide strategic, operational, and tactical regulatory guidance in support of CMC development of early-stage cell and gene therapy products.
• Work closely with Subject Matter Experts on internal and joint project teams to ensure the CMC strategy is aligned with regulatory agency expectations/requirements and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
• Identify and assess regulatory risks and critical-path activities associated with CMC activities and work to identify regulatory strategies to mitigate risks.
• Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs.
• Responsible for overall planning, coordinating, and developing high quality, compliant and timely regulatory submissions that require extensive interaction with departments outside of Regulatory Affairs and outside of CTMC.
• Responsible for preparing (planning and coordination, authoring, reviewing, adjudicating comments, and finalizing) CMC sections for regulatory filings.
• Actively collaborate with biotech companies and MD Anderson Cancer Center to ensure completion and timely delivery of nonclinical and clinical sections for regulatory filings.
• Ensure submission readiness at the document-level, including document formatting and PDF generation, bookmarking and hyperlinking.
• Compile, publish and submit in eCTD via the Electronic Submissions Gateway using Veeva Vault RIM.
• Initiate or contribute to process improvements (e.g., policies, SOPs, work instructions) which have a significant impact on business.
• Evaluate change proposals for regulatory impact and lead regulatory strategy for CMC information amendments.
• Other duties as required.

Qualifications:

• Master’s degree in a relevant science discipline, or PhD preferred, minimum Bachelor’s degree required.
• 10 yr.’s relevant experience including 8+ yr.’s working within the biotech/pharmaceutical industry and 5+ yr.’s of biotech/pharmaceutical Regulatory Affairs CMC experience or equivalent combination of education and experience.
• Prior experience with cell and/or gene therapy products.
• Extensive experience in the preparation, submission, and maintenance of CMC (Module 3) sections.
• Strong knowledge of the fundamentals of CMC development (e.g., process development, analytical development, tech transfer, quality control, quality assurance).
• Demonstrated ability to effectively apply CMC guidance/principles in the authoring of Module 3 documents and develop critical regulatory documents for regulatory filings with a focus on the FDA.
• Track record of successful interactions with regulatory authorities on CMC topics.
• Ability to effectively work individually, within a cross-functional team, as well as with external partners and vendors.
• Combine strategic thinking with the ability to execute, both individually and as a part of a team, to achieve operational excellence in the face of a challenging goal.
• Ability to “roll up your sleeves” to get it done.
• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills.
• Strong attention to detail and an ability to prioritize effectively.
• Proficient in various computer applications such as Office suite, Veeva, Smartsheet, etc.

Working Conditions, Equipment, 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.

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 four INDs, each ahead of schedule, 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 state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 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 novel corporate structure. 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.

Responsibilities

CTMC is looking for a highly motivated Project Leader with exceptional scientific and communication skills to support our Houston, TX development and manufacturing site. 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. Prior experience leading and managing complex and cross-functional projects is required, and a strong understanding of CMC and drug development is preferred. This role will report to the Head of Project and Alliance Leadership.

• Directly manage multiple development projects, leading cross-functional teams through strategy, planning and execution of projects, 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 with biotechnology companies.
  • Drive novel cell therapy projects through IND studies to first-in-human clinical trials; leading at least 2 programs to the clinic over the first 12 months.
  • 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 those regulatory strategies are clearly communicated.
  • Manage the alliance with partners developing innovative, curative cell therapies. Use scientific knowledge and thinking to propel projects through execution.
• Prepare, track and report 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 departments to move projects from development space into the GMP environment and through IND submission.
• Other duties as required            

Qualifications/Skills

• Bachelor’s degree or Master’s in engineering, science, or related field required, PhD preferred.
• 12+ yr.’s. 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.
• Demonstrate familiarity with Biologics development to IND, required.
• Previous experience with Cell Therapy manufacturing preferred.
• High-level of communication skills required, both written and verbal.
• Demonstrate organization, focus and diplomacy skills.
• Demonstrate high level of emotional intelligence and the ability to create a collaborative trusting team.
• Possess mindset focus on strategic thinking, data-driven decision making and effective communication.
• Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint.
• Previous experience with matrix project management and/ or agile project management is beneficial.
• Ability to work onsite as needed (remote candidates will be considered with some travel required 25% of the time), relocation preferred.

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
• 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.

About CTMC

     CTMC (Cell Therapy Manufacturing Center), a joint venture between Resilience and MD Anderson Cancer Center, is a first-of-its-kind biotech located in the world-renowned Texas Medical Center created to accelerate cell therapies moving from research to patients. CTMC develops and manufactures cell therapies invented at MD Anderson, as well as biotechs, including a variety of modalities such as CAR-T, TIL, ETC and TCR-T.  We aim to file 4 INDs in the first 12 months as we work closely with MDACC research and clinical faculty to bring impactful cell therapies to cancer patients. Our partnership with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in their first two years gives CTMC access to advanced technology and processes and enables us to stay at the cutting edge of biomanufacturing practices. Through the capabilities within CTMC and our alliance with MD Anderson Cancer Center and National Resilience, we co-develop cell therapy products with biotech companies and help them industrialize and accelerate their innovative therapeutics to reach the clinic quicker and ultimately maximize patient impact.    

     CTMC is housed in a state-of-the-art 60,000sqft development and manufacturing facility in the Texas Medical Center with an integrated team of 75 industry veterans and scientists with a depth of cell therapy expertise.  The unique structure of our joint venture with two highly established partners gives the organization financial stability and a long-term horizon, despite the current environment of funding uncertainty in the biotech field.  Our broad scope and novel corporate structure allow employees a plethora of development opportunities for members of our team.  We are passionate about aggressively bringing life-saving cures to patients and achieving it through a cohesive team-first culture and balanced work-life environment for our staff.  If you feel you can contribute to our mission and be part of a newly imagined biotech, we welcome your application. 

Responsibilities

• Perform cleaning, documentation, processing, and materials procurement for the manufacturing department.
• 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.   
• Develop SOPs 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. 
• Coordinates with various departments, such as QA, QC, Material Management, Process Development, and Project Management when required to ensure deadlines are met. 
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices. 
• Assist support for routine maintenance activities when needed.  
• Ensure transparent communication with staff, teams, support functions, and site leadership team.   
• Establish, drive and report key performance indicators in alignment with Cell Therapy Manufacturing and Biologics Development goals. 
• Other duties as assigned. 

Qualifications/Skills

• B.S. preferred, or equivalent education and experience.
• 2+ yr.’s experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required.
• Previous experience with the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Incubators, Cell Stacks, Cobes, or Lovos preferred.
• Previous experience with technical writing required.
• 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. 
• Previous experience with manufacturing calculations and conversions using mathematics and critical thinking preferred or ability to learn.
• Able to provide input to develop new SOPs for new and incoming equipment. 
• Proficient with Microsoft Office: Word, Excel, and Outlook.
• Previous GMP Experience preferred.
• Ability to work a flexible schedule based off business needs.

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
• Facsimile
• Telephone
• Manufacturing equipment

Physical Demands-  

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

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, 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 four INDs, each ahead of schedule, 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 state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 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 novel corporate structure. 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.

Position Summary

CTMC is seeking a Chief of Staff to join our team and support our CEO and senior staff in taking our development efforts to the next level.  Flexibility to handle a wide variety of tasks and rapidly adjust priorities is essential. The successful candidate will be responsible for ensuring a strong market presence and making significant contributions to our unique partnering model.

As a trusted expert in the rapid clinical development of partnered therapeutic programs, CTMC has gained notoriety for our unique partnering model. The Chief of Staff will work closely with leadership to assist with potential partner engagement.

We are seeking a candidate who thrives in a fast-paced, mission-driven environment and is prepared to engage in business and technical discussions. If you are a highly motivated individual with a passion for innovation and a strong track record in supporting company objectives and missions, we encourage you to apply for this exciting opportunity with CTMC.

Responsibilities

• Manage transparent and informative correspondence, presentations, reports and other documents on behalf of the senior leadership team and CEO, ensuring accuracy and professionalism with internal and external stakeholders.
• Assist CTMC leaders in outreach to potential partners (from Houston to a worldwide reach), representing company as needed. Enhance CTMC’s presence and leadership in the Houston community.
• Coordinating initial partnering discussions with various external PI’s with active or potential collaborative projects.
• Maintain excellent relationships with external stakeholders including board members, partners, investors, the media, government organizations and the research community.
• Manage initiatives, projects, objectives, and timelines with communication of oversight activities to leadership.
• Facilitate collaborative activities across internal teams to maintain high-impact engagement and a positive work culture.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in science, or related field required.
• 9+ yr.’s of relevant work experience, including 3+ yr.’s of management or supervisory experience at a Chief of Staff level or closely related title or equivalent combination of education and experience.
• Previous experience with cell therapy preferred.
• Previous experience handling various aspects of projects.
• High level of emotional intelligence and the ability to work on a collaborative, trusting team.
• Focus on strategic thinking, data-driven decision making, and effective communication.
• Strong communication skills: both written and verbal.
• Strong presentation skills.
• Demonstrated negotiation and vendor management experience a plus.
• Ability to be flexible and shift tasks as needed to accommodate business needs.
• Advanced experience in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment and 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 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.