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

PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth, dignity, and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

• Practices the Caring and Serving Model

• Delivers personalized service using HM Service Standards

• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)

• Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience.

• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

• Displays cultural humility, diversity, equity and inclusion principles

• Actively supports the organization's vision, fulfills the mission and abides by the I CARE values

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

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

KNOWLEDGE, 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.)

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

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.