Supervisor, Manufacturing

CTMC; Houston (TX); On-site; USD 50,000 - 55,000; Full time

Job summary

An innovative biotech joint venture is seeking a dedicated Supervisor for Manufacturing to lead CAR-T projects and ensure GMP compliance. This role involves managing cross-functional teams, preparing reports, and implementing training programs. Join a passionate team committed to advancing cell therapies and making a difference in patients' lives. With a focus on professional growth and a collaborative culture, this position offers the opportunity to contribute to groundbreaking medical advancements in a state-of-the-art facility. If you are driven by a mission to deliver novel cures and thrive in a dynamic environment, we invite you to apply.

Qualifications

• 7+ years in manufacturing (viral vector, cell therapy, or biotech).
• 1+ year in a management role with strong GMP knowledge.
• Experience with technical writing and QMS systems.

Responsibilities

• Manage CAR-T projects and coordinate across functional groups.
• Draft and implement SOPs for GMP compliance.
• Train Manufacturing Associates on new processes.

Skills

GMP Practices

Technical Writing

Manufacturing Calculations

Leadership

Time Management

Troubleshooting

Education

Bachelor’s Degree in a Scientific Field

Tools

Veeva

TrackWise

Master Control

Microsoft Office

Job description

Join to apply for the Supervisor, Manufacturing role at CTMC

Join to apply for the Supervisor, Manufacturing role at 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

• Manage assigned CAR-T projects as required, 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 Cell Therapy equipment: Incubators, Prodigies, Lovos, Cues, etc.
• Draft and revise a training program to ensure GMP compliance and operational compliance with CT 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.
• Train Manufacturing Associates on New Processes.
• Other duties as assigned.

Qualifications/Skills

• Bachelor’s degree in a scientific field; or equivalent combination of education and experience.
• 7+ yr.’s experience in a related manufacturing environment (viral vector, cell therapy, or biotech), experience with viral vector or TIL processes a plus.
• 1+ 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 a QMS system, such as Veeva, TrackWise, or Master Control required.
• Previous experience with technical writing required.
• Previous experience with preparation and delivery of reports/data to internal or external parties.
• Able to lead, train 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.
• Previous experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges preferred.
• Strong organizational and time management skills.
• Proficient with Microsoft Office: Word, Excel, and Outlook.
• 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 functionsin accordance withthe 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

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