Associate III, Manufacturing - Houston, United States - CTMC

Description

Job Description

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.