Why Work Here?


Our mission at CTMC is to bridge the gap between the academic research environment, state of the art cell therapy development and manufacturing technology platforms, and leaders in clinical cancer care to enable rapid advancement of novel therapeutics from concept to clinic.

Our joint venture between MD Anderson Cancer Center, the world-renowned cancer center, and Resilience, a network of advanced biopharmaceutical solutions, creates a collaboration of cancer experts and state of the art development and manufacturing technologies. This unique business model has created a biotech-like engine within the prestigious Texas Medical Center so we can bring life-saving medicines more quickly and effectively to patients.


In this new era of precision medicine, we are shaping the direction of cancer treatment by combining the best talent from biotech and academia to create a dynamic and stimulating work environment with opportunities for growth – both personally and professionally. This drive and passion to create life-changing cancer treatments for patients is at the forefront of all that we do.


If you are seeking the next challenge with the desire to contribute to our unified goal of treating patients in their battle with cancer, contact CTMC at: hr@ctmc.com

Job Openings


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 over 80 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. 


 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 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 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.

Apply Now

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 over 80 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. 


 Responsibilities

  • Perform cleaning, kitting, documentation, processing, and materials procurement for the manufacturing department.
  • Request and prepare materials for manufacturing operations while maintaining proper inventory levels in the cleanroom at all times.
  • Maintain aseptic technique during processing to ensure quality and integrity of cellular drug products.
  • Execute master batch production records in a timely manner and maintain accurate documentation with FDA’s Good Manufacturing Practices.
  • Perform error free calculations, including but not limited to cell doses, dilutions, and total cell count or total viable cell count numbers.
  • Provides input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment.
  • Provide input on manufacturing process optimization based on working knowledge and understanding of project for which individual is an SME.
  • Operate standard cleanroom equipment: Incubators, BSCs, and Centrifuges.
  • Operate the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Incubators, Cell Stacks, Cobes, or Lovos.   
  • Develop and create new SOPs for new and incoming equipment.
  • Troubleshoot cell processing operation and equipment, escalating issues as needed.
  • Assist in SOP revisions and creating new batch records for tech transfers.
  • Perform or assist in deviation writing, CAPAs, Root Cause Analysis, or Change Controls. 
  • Coordinate with various departments, such as QA, QC, Material Management, Process Development, and Project Management when required to ensure deadlines are met. 
  • Train junior level Associates on manufacturing processes; act as SME.
  • Assist with training staff on proper operations and documentation in cGMP cleanroom facilities; including but not limited to Gowning Qualifications and Aseptic Process Simulation for new hires.
  • Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices. 
  • Assist with support for routine maintenance activities.
  • Ensure transparent communication with staff, teams, support functions, and site leadership team.
  • Meet and reports 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 equivalent education and experience.
  • 3+ yr.’s experience in a related manufacturing environment (cell therapy or biotech) required.
  • 3+ yr.’s experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required. 
  • Previous experience with one or more of the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Incubators, Cell Stacks, Cobes, or Lovos preferred. 
  • Proficient with Microsoft Office: Word, Excel, Outlook, PowerPoint, and Teams.
  • Previous GMP Experience required.
  • Previous experience performing accurate calculations and lab measurements required.
  • 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. 
  • Able to troubleshoot cell processing operations and equipment.
  • Meticulous attention to detail in terms of documentation, following procedure SOPs, and performing functions as it pertains to the Batch Record.
  • Able to train and lead junior level Associates on all aspects of the manufacturing process for which the individual is an SME.
  • 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. 

Apply Now

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

  • Learn and observe the execution of different state-of-the-art cell based or molecular biology techniques which are typically used in the development of cell therapies.  
  • Maintains cultures of primary T cells and cancer cell lines with proper documentation.  
  • Performs T cell-based assays such as IFNg ELISA. 
  • Performs genomic DNA extractions to support molecular assays. 
  • Support management of assay reagent inventory as well as other support tasks laid out by their supervisor. 
  • Participates in lab meetings and other collaborative activities.  
  • Showcases achievements/learnings with a presentation at the conclusion of internship to the broader development team. 
  • Other duties as required.

Qualifications/Skills

  • High School Diploma required; enrollment in a minimum Bachelor’s degree program in a relevant field preferred.
  • Previous laboratory experience preferred.
  • Able to learn testing procedures and work utilizing standard operating procedures.
  • Able to work in a fast-paced environment.
  • Demonstrated ability to be nimble, collaborative, and eager to contribute.
  • Good communication skills.
  • Proficient with MS Office (Excel, Outlook, etc.).

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
  • Occasional lifting, pushing, and pulling up to 10 lbs. 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. 

Apply Now

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

Summer Internship in the PD cell therapy group: 

The PD intern will be exposed to T-cell therapy drug development in industry and learn about the different modalities and their applications. Over the course of the internship, the candidate will: 

  • Observe and discuss the different T-cell expansion processes required for T-cell therapy drugs in development at CTMC with his team members.
    1. observe hands-on cell therapy process development work with mentors in the laboratory as a learning tool, and eventually participate with execution. 
    2. become knowledgeable on the processes observed and be able to discuss the different approaches with the team in group meetings.   
  • Become familiar with aseptic technique and perform contamination-free cell culture.
    1. training on aseptic technique after the observation phase. 
    2. successfully perform processes requiring aseptic technique.  
  • Train on the use of various cell processing devices and equipment
    1. train on multiple devices used in cell therapy production, including automated and semi-automated cell processing devices. 
    2. following training, the candidate will be expected to be able to independently operate equipment and be able to understand the basic mechanisms of operation for the equipment.  
  • Participating in advancement of project by assisting the team.
    1. post-observation phase: the candidate is expected to add value to the team by contributing to the ongoing work to the extent of their capacity.  
    2. continuous learning of new skills under the team’s guidance 
    3. present their work at weekly team meetings.  
  • Potential to carry a small study independently and within the scope of a larger project’s activities.
    1. If the candidate shows great understanding of the processes and the ability of doing autonomous works, the candidate could be given a small study to perform independently (or assisted) under the guidance of the team or the designated mentor.  

Qualifications/Skills

  • High School Diploma required; enrollment in a minimum second year Bachelor’s degree program in a relevant field preferred.
  • Desire to learn cell therapy development.
  • Previous laboratory experience preferred.
  • Able to be a great team player.
  • Able to learn testing procedures and work utilizing standard operating procedures.
  • Able to work in a fast-paced environment.
  • Demonstrated ability to be nimble, collaborative, and eager to contribute.
  • Good communication skills.
  • Proficient with MS Office (Excel, Outlook, etc.).

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
  • Occasional lifting, pushing, and pulling up to 10 lbs. 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. 

Apply Now

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

  • Develop robust processes of formulation, fill and finish, and cryopreservation for chimeric antigen receptor T (CAR T) and Tumor-Infiltrating Lymphocytes (TIL) cell products.
  • Design and execute studies on formulation, fill/finish, and cryopreservation of candidate cell therapy product.
  • Evaluate new cryobiological technologies. 
  • Implement process advancements for scaling-up and introduction into a GMP manufacturing environment.
  • Lead technology transfer activities and training manufacturing staff on new processes and equipment,
  • Monitor process performance during clinical manufacturing via data tracking, trending, and analysis.
  • Design and conduct experiments in development laboratory to support process changes, generate process robustness data, and/or resolve manufacturing non-conformances.
  • Draft technical documents including development reports, process descriptions, risk assessments, SOPs, MBRs, and regulatory filing sections.
  • Act as internal expert and maintain state-of-the-art knowledge in the field of cellular cryopreservation and cryobiology.
  • Other duties as assigned.

Qualifications/Skills

  • Ph.D. in a related scientific/engineering field required.
  • 1+ years’ experience in a related field, preferably in the biotech industry or equivalent combination of education and experience.
  • Strong knowledge and hands-on experience with cell therapy process development and cryopreservation; cell therapy experience required.
  • Highly desired experience:

-Formulation science experience with cryoprotectant additives.

-Demonstrated aseptic cell handling skills.

-Experience working in or supporting a cGMP-regulated environment.

-Hands-on experience with common cell therapy laboratory equipment and technology platforms

  • Familiarity with the following is a plus:

-solid background in cell therapy manufacturing processes

  • Proficient with MS Office (Excel, Outlook, etc.) and statistical software (Prism, JMP).
  • Strong scientific understanding of the fundamental principles of cryopreservation and cell therapy.
  • 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.

Working Conditions, Equipment, Physical Demands 

The incumbent in this position works in a lab and 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.
  • Occasional lifting, pushing, and pulling up to 10 lbs. 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. 

Apply Now

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

  • Manage all Viral Vector projects 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 Viral Vector equipment: Incubators, CellStacks, Kros-Flo, Chromatography skids.
  • Draft and revise a training program to ensure GMP compliance and operational compliance with viral vector 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.
  • Other duties as assigned.  

Qualifications/Skills

  • Bachelor’s degree in a scientific field; or equivalent combination of education and experience.
  • 12+ yr.’s experience in a related manufacturing environment (viral vector, cell therapy, or biotech). Experience with CAR-T or TIL Cell Therapies, a plus.
  • 5+ 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 standard cleanroom equipment: Incubators, BSCs, and Centrifuges preferred. 
  • Previous experience with a QMS system, such as Veeva, TrackWise, or Master Control required.
  • Previous experience with preparation and delivery of reports/data to internal or external parties.
  • Able to lead 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.
  • Strong organizational and time management skills. 
  • Proficient with Microsoft Office: Word, Excel, and Outlook.
  • 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. 
  • 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. 

Apply Now