cGMP Specialist

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 with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing procedures
• Proficiency in spreadsheet, word processing and presentation software
• Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented
• Ability to mentor and coach department personnel
• Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III etc.)

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• Collaborates with cross functional teams including research, process development, quality assurance and quality control.
• Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs.
• Participates in multi-functional project teams, as necessary.

SERVICE ESSENTIAL FUNCTIONS

• Participates in internal audits and external inspections by Regulatory Agencies.
• Responds to calls/alarms off hours and weekends for facility systems and equipment failures.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.
• Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.
• Assists with discrepancy inspections.

FINANCE ESSENTIAL FUNCTIONS

• Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs.
• Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.

SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE

• Uniform: No
• Scrubs: No
• Business professional: Yes
• Other (department approved): No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.

• On Call* Yes

TRAVEL**
**Travel specifications may vary by department**

• May require travel within the Houston Metropolitan area No
• May require travel outside Houston Metropolitan area No

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