Sr cGMP Specialist - QC Analytical Radiochemist

Houston Methodist; Houston (TX); On-site; USD 75,000 - 115,000; Full time

Job summary

An established industry player is seeking a Sr. cGMP Specialist to ensure compliance with quality operations in the manufacturing of therapeutics and devices. This pivotal role involves overseeing adherence to SOPs, guiding junior team members, and collaborating with various teams to transition processes to compliant standards. The ideal candidate will have extensive experience in a regulated environment, ensuring product quality and safety while contributing to innovative policies. Join a dynamic team dedicated to delivering high-quality products to patients and customers, while continuously seeking improvement and growth opportunities.

Qualifications

• 5+ years in biotech or pharma with cGMP manufacturing experience.
• Bachelor's degree required; Master's preferred.

Responsibilities

• Ensure adherence to SOPs and cGMP regulations.
• Conduct internal audits for FDA and cGMP compliance.

Skills

Organic Synthetic Chemistry

Analytical Chemistry (HPLC)

cGMP Compliance

Quality Control

Technical Expertise in Manufacturing

Education

Bachelor's Degree in Arts or Science

Master's Degree

Tools

FDA Regulations

SOP Development

Job description

Job Description: Sr. Current Good Manufacturing Practices (cGMP) Specialist at Houston Methodist

The Sr. cGMP Specialist is responsible for ensuring adherence to Standard Operating Procedures (SOPs) and cGMP regulations related to the manufacture of therapeutics and devices. This role includes overseeing compliance in quality operations, reviewing procedures, verifying equipment and facility cleanliness, ensuring proper gowning and labeling, maintaining correct operating parameters, executing protocols per SOPs, and guiding junior team members. As a senior department member, this position contributes to developing policies and procedures for delivering novel products to patients and customers.

Preferred Additional Skills

• Knowledge and experience in organic synthetic chemistry
• Understanding of basic analytical chemistry, including HPLC
• Experience or willingness to work with radioisotopes in a radiochemistry lab, complying with safety guidelines
• Experience or willingness to operate in a highly regulated radiopharmaceutical manufacturing environment in compliance with FDA cGMP

Essential Functions

People

• Provide work direction to authorized users in production or quality control
• Collaborate with research, process development, QA, and QC teams
• Assist research teams in transitioning processes to compliant cGMP SOPs and participate in multi-functional projects

Service

• Participate in audits and inspections, reporting findings to management
• Respond to off-hours alarms and facility issues
• Serve as a technical expert supporting department functions
• Review testing documentation across departments

Quality/Safety

• Ensure product supply meets quality requirements and demand schedules
• Conduct internal audits for FDA and cGMP compliance

Finance

• Use resources efficiently, manage time effectively, prioritize tasks

Growth/Innovation

• Contribute to defining quality policies with QA leadership
• Assist in defining testing requirements, developing protocols, and updating SOPs
• Translate research processes to manufacturing
• Seek continuous learning opportunities and lead improvement projects

This description may be supplemented with additional duties as assigned, with revisions as necessary by Houston Methodist.

Qualifications

• Bachelor's degree in Arts or Science; Master's preferred
• Minimum five years of biotech or pharma experience with cGMP manufacturing exposure
• Experience with equipment validation, facility commissioning, audits, batch review, and regulatory inspections preferred