Sr. cGMP Specialist-QC Analytical Radiochemist

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) SERVEDRefer 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

• Actively 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 polici