Welcome page Returning Candidate? Log back in! Senior cGMP Specialist - Cyclotron Facility HM Research Institute Job Locations US-TX-Houston Category Quality and Research Position Type Full-Time Department Cyclotron Shift 1st - Day Overview

At Houston Methodist, the Sr. Current Good Manufacturing Practices (cGMP) Specialist 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 all 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 and the proper guidance of junior level team members. 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 Skillset is preferred:

Demonstrated knowledge and experience in organic synthetic chemistry;Knowledge in basic analytical chemistry, including High Performance Liquid Chromatography (HPLC);Experience or willingness to handle radioactivity isotopes, working in a radiochemistry Lab environment in compliance with State radiation safety guidance;Experience or willingness to work in a highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. Houston Methodist Standard

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 ModelDelivers personalized service using HM Service StandardsProvides 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 jobDisplays cultural humility, diversity, equity and inclusion principlesActively supports the organization's vision, fulfills the mission and abides by the I CARE values Responsibilities

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.

Qualifications

EDUCATION

Bachelor of Arts or Science degreeMaster's degree preferred

WORK EXPERIENCE

Five years of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operationsExperience performing equipment validation (IQ/OQ/PQ), facility commissioning, internal/ external audits, batch record review and hosting regulatory inspections preferred License/Certification

LICENSES AND CERTIFICATIONS - REQUIRED

N/A KSA/ Supplemental Data

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 evaluationsSufficient 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 securityAbility 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 principlesFamiliar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing proceduresProficiency in spreadsheet, word processing and presentation softwareAbility to work under pressure and balance many competing priorities; highly responsive and solution/action orientedKnowledge 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 personnelDemonstrates 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 NoScrubs NoBusiness professional YesOther (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 NoMay require travel outside Houston Metropolitan area No Company Profile

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.

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Equal Employment Opportunity

Houston Methodist is an Equal Opportunity Employer.

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