Associate Director, Manufacturing

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

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

Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.

Responsibilities

• Lead, mentor, and develop a team of 20 manufacturing managers and associates, focusing on driving high performance, fostering employee engagement, and ensuring overall job satisfaction.
• Manage the evaluation, implementation and execution of electronic systems, ensuring seamless integration with existing processes and driving operational efficiency across the team.
• Oversee capacity utilization and modeling for GMP suites, equipment, and personnel, optimizing resources to ensure maximum efficiency and meet production goals. This includes potentially evolving shift scheduling from the current 5/8 dynamic scheduling to fit-for-purpose models based on forecasted demand.
• Coordinate with Process Development, Quality Control, Quality Assurance, and Project Leadership to ensure timely completion of all Technical Transfers.
• Drive continuous improvements in all Manufacturing operations, focusing on enhancing quality and safety standards.
• Serve as Manufacturing Lead for audits, inspections, submissions and regulatory requests.
• Ensure timely close out of all deviations, CAPAs, and change controls related to all Manufacturing Processes.
• Maintain a high level of compliance through effective monitoring and reporting of key metrics to CTMC’s Quality Council.
• Develop innovative approaches to improve effectiveness of training program for manufacturing staff to enable rapid onboarding as well as overall operational flexibility through cross-training.
• Promote a culture of continuous improvement, collaboration, and safety, while leading by example to maintain a productive and secure work environment.
• Enhance existing relationships with local organizations (i.e. community colleges) to create a talent pipeline
• Other duties as assigned.

Qualifications/Skills

• Bachelor’s degree in scientific field, or equivalent education and experience.
• 12 yrs. experience in a related manufacturing environment (cell therapy or biotech)
• 6 yrs. experience in management or supervisory role.
• Preferred- 5 Yrs Exp in Experience with Cell Therapy, including troubleshooting processing and equipment
• Previous experience with implementation or use of an ERP, LIMs, CMMS, or MES systems
• Strong knowledge of GMP Practices and FDA requirements required.
• Strong organizational skills to efficiently lead an organization of 20 personnel.
• Previous experience with personnel growth and development plans including periodic and annual reviews.
• Previous experience in technical authoring, including SOPs, batch records, protocols and technical reports.
• 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 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.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Able to assist and be on call in a flexible schedule including nights, weekends, and holidays.

Working Conditions, Equipment, Physical Demands

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.