Sr. Manager, Digital GxP Systems bei CTMC

Location: On site in Houston, TX
Department: Tech Ops
Reports to: Chief Technical Officer

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

The Sr Manager Digital GxP Systems is tasked with developing standard approaches and components that will be used to build LIMs and MES recipes and integration throughout the CTMC network. The role will assist local teams in the Design, Development, Delivery and CSV of the LIMs and MES solutions for CTMC. 

• Develop and integrate LIMs and MES common and site-specific components. 
• Benchmark on innovative solutions (external and internal to CTMC).
• Dynamically adapt road map to site evolution/strategic directions, and new trends/issues.
• Establish a strong site culture based in CTMC values, expectations, and operational excellence standards.
• Support LIMs / MES solutions deployment and start up activities.
• Serve as System owner for LIMs and MES systems
• Work with site resources towards replication & standardization to drive value and implement the appropriate technical solutions.
• Evaluate emerging technologies and implications to existing CTMC Digital systems.
• Maintain open communication with MES / LIMs vendor(s) to address needs in standard solutions or via functional packs.
• Evaluate and translate functional requirements into technical solutions.
• Ensure project and/or validation documentation is maintained during lifecycle & release management.
• Develop assist in the creation and maintenance of the LIMs and MES interfaces with other Digital systems.
• Provide guidance and direct activities to ensure manufacturing facility and support areas comply to applicable regulations and industry best standards.
• Lead and participate in projects within the organization’s objectives and project timelines and participate in cross-functional projects as the quality subject matter expert.
• Collaborate with other leaders across the organization and assist in the continuous improvement.
• The role is responsible for system design, implementation, and lifecycle management of LIMs and MES systems.
• Provide leadership or support in the implementation of LIMS and MES systems, drawing on prior experience with LabVantage and other LIMS platforms, as well as commercial EBS solutions such as MES.
• Collaborate with key stakeholders to capture business requirements and translate them into functional specifications.
• Oversee or prepare system design documentation, including URS, FRS, DS, configuration specifications, and data flow diagrams.
• Provide technical guidance on master data setup, workflows, system configuration, and reporting functions.
• Prepare, review, and approve GMP documentation (e.g., Non-Conformances, Procedures, Protocols, Specifications, and Change Controls) to ensure quality and user requirements are met.
• Participate in computer system validation (CSV), computer software assurance (CSA), and qualification activities according to GAMP 5 and 21 CFR Part 11.
• Maintain validation status and support periodic reviews and change management processes.
• Ensure data integrity and regulatory compliance throughout the system lifecycle.
• Conduct investigations and impact assessments for deviations, audit findings, and system issues related to electronic systems.
• Support internal and external audits and inspections by regulatory authorities such as the FDA.
• Train and mentor users and administrators on system functionality and compliance requirements.
• Work with vendors and IT teams to facilitate system upgrades and support structures.
• Remain informed about industry trends and emerging technologies in digital quality systems.
• Other duties as required.

Qualifications/Skills

• Bachelor’s Degree in IT, Engineering, or related technical field.
• 12+ years of GxP experience in Pharmaceutical Industry or equivalent combination of education and experience.
• 5+ years of strong experience with LIMS and MES system implementations.  
• Professional experience working in a GXP, regulated environment.
• Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP).
• Effective people and team leadership skills.
• Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities.
• Ability to cross functionally collaborate.
• Excellent written and oral communication skills.
• Demonstrate creativity, analytical thinking, and the ability to troubleshoot and solve problems.
• Knowledge of cloud solutions and architecture.
• History of promoting safety and maintaining a safe work environment
• Demonstrated adherence to compliance for internal and external quality guidance.
• Demonstrate and promote Operational Excellence
• Effectively encourage knowledge sharing and education
• Evaluate and translate functional requirements into technical solutions.
• Proven technical ability to develop and integrate MES and LIMs solutions.
• Excellent time management skills with a proven ability to meet deadlines. 
• Strong analytical and problem-solving skills. 
• Proficient with Microsoft Office Suite or related software. 

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.