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cGMP Specialist
- Clinical Cell Therapy

The cGMP Specialist
- Clinical Cell Therapy is responsible for performing complex, time-sensitive, and highly specialized technical procedures for the processing, evaluation, and preparation of cellular therapy products used in hematopoietic stem cell transplantation, CAR-T therapy, and other advanced cellular treatments. After completing structured training and competency assessment, the Specialist independently performs routine and advanced processing tasks, supports cleanroom operations, maintains accurate documentation, and ensures compliance with regulatory and accreditation requirements.

This role plays a vital part in safeguarding the integrity, sterility, viability, and traceability of irreplaceable, life-saving cellular products.

Core Competencies:

• Sterile gowning and cleanroom behavior
• Aseptic technique and controlled material handling
• Basic understanding of cGMP principles and data integrity

The cGMP Specialist I / Production supports the clinical translation of advanced therapeutic platforms, including nucleic acid–based therapies (including RNA formulated in lipid nanoparticles [LNPs]) and cell-based therapies (e.g., MSC, CAR-T, TCR-T, Treg) within the Office of Translational Production & Quality at Houston Methodist Research Institute. The candidate is expected to support the manufacture of cell-based therapies and nucleic acid–based therapeutic products under cGMP and cGTP conditions through technical knowledge, aseptic handling, formulation, and processing of nucleic acid–based materials and cell therapy products, depending on the assigned platform.

Core Competencies:

• Sterile gowning and cleanroom behavior
• Aseptic technique and controlled material handling
• Basic understanding of cGMP principles and data integrity
• Environmental monitoring awareness
• Product labeling, traceability, and chain of custody

The cGMP Specialist I / Production is expected to achieve proficiency on processes and manufacturing procedures related to clinical products under specific projects, in order to assure that the products have the safety, identity, strength, quality, and purity that it purports or is represented to possess for our patients and customers. As a member of the Office of Translational Production & Quality, this position will actively participate in continuous quality improvement initiatives, pursue continuing education opportunities and work within the cGMP and cGTP guidelines, following regulatory standards such as FACT, CAP and AABB, as applicable.

At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist position is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. Additionally, this position will be responsible for assisting senior team members with aspects of compliance associated with the quality operations including but not limited to; review of procedures, verification of equipment and facility cleanliness, proper gowning, correct material labelling, correct operating parameters for equipment and proper execution of protocols in accordance with approved SOPs.

FLSA STATUS:
Exempt

QUALIFICATIONS

EDUCATION

• Bachelor's degree
• Master's degree preferred

EXPERIENCE

• Three years of experience in the biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations
• Experience performing equipment validation (IQ/OQ/PQ), facility commissioning, internal/ external audits, batch record review and hosting regulatory inspections preferred

SKILLS AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
• Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
• Familiar…