At Houston Methodist, the Senior Current Good Manufacturing Practices (cGMP) Specialist - Nuclear Pharmacy Technician position is responsible for adherence to Standard Operating Procedures (SOP's), cGMP and USP 797/823/825 regulations, and the Texas Board of Pharmacy pertaining to the manufacture and dispensing of radioactive therapeutic and diagnostic imaging agents for both clinical and research use under the direct supersion of the Authorized Nuclear Pharmacist (ANP). Additionally, this position will include duties such as compounding of radiopharmaceuticals while maintain a sterile environment, quality control of finished product, production of radiopharmaceuticals, organization of approved documents, and assist with radiopharmaceutical dispensing. As a senior member of the department, this position will actively contribute to the development of policies and procedures for the delivery of novel products to our patients and customers.

Additional Information: Priority given those applicants with One year of pharmaceutical industry experience with exposure to cGMP manufacturing operations or; PET cGMP or SPECT nuclear pharmacy (preferred), Texas Pharmacy Technical license or intent to obtain, ACPE approved Sterile Compounding Training for Pharmacy Technicians or intent to obtain.

PEOPLE ESSENTIAL FUNCTIONS

• Provides work direction of authorized core users working in either production or quality control.

• 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 SOP's and participates in multi-functional project teams as necessary

SERVICE ESSENTIAL FUNCTIONS

• Participates in internal audits and external inspections by Regulatory Agencies and reports findings to direct management.

• Responds to calls/alarms off hours and weekends for facility systems and equipment failures.

• Serves as technical subject matter expert in support of department functions.

• Reviews testing documentation from all cross-functional departments

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.

• Conducts internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.

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

• Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies.

• 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.

• Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.

• Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.

• Identifies opportunities for improvement and leads projects which result in innovative solutions that increase the level of compliance and efficiency of the team.

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 of Arts or Science degree

• Master's degree preferred

WORK EXPERIENCE

• Five years of biotechnology or pharmaceutical industry experience 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

• 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.)

• Ability to mentor and coach department personnel

• Demonstrates highly effective communication skills and the ability to lead both informal/formal educational sessions to include classroom/seminar instruction in cGMPs and specialized topics related to compliance and best practices

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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.

Equal Employment Opportunity

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.