cGMP Specialist - TP&Q - HMDDP Core

The cGMP Specialist I / Production is responsible for the production and supervision of aseptic manufacturing of drugs and devices in the Houston Methodist Drug and Device Facility. The candidate is expected to independently develop procedures (including batch records), forms and run protocols of fill finish, RNA vaccines and lipid nanoparticle formulations to support Phase 1 and Phase 2 clnical trials.This will involve performing a wide variety of biologic manufacturing and testing methods to determine identity, purity, impurity, and strength.

In addition, the cGMP Specialist I/Production supports validation/qualification efforts, acts as a resource for problem solving, incident and deviation documentation, corrective action and troubleshooting for procedures and unexpected events, and consults with management if unable to resolve issues.

Core Competencies related to the job function:

- Sterile Gowning

- Cleanroom operating procedures

- Aseptic Technique

- Environmental Monitoring

- Sterilization Techniques

- Product Label Development

- Incident, deviation and CAPA procedures

- Change control procedures

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 product has 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 guidelines, following regulatory standards such as 21 CFR parts 210/211 and ICH Q7

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.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

EDUCATION

• Bachelor's degree

• Master's degree preferred

WORK 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