Location
Humble, TX | United States
Job description
QC Manager/Radiochemist
RadioMedix Inc., a Biotechnology Company headquartered in Houston, Texas, is seeking an experienced QC Manager/ Radiochemist to work its newly constructed GMP radiopharmaceutical manufacturing facility. The successful candidate will play a key role in R&D, development, manufacturing of radiopharmaceuticals and GMP investigations. The focus of the position will be to focus on high priority projects at RadioMedix that will be integral to upcoming clinical trials. This is a newly created position with potential for significant growth.
We’re a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the nuclear medicine landscape.
Roles/Deliverables The QC Manager/Radiochemist will provide technical expertise to support development of analytical methods and procedures that will be used to demonstrate Manufacturing and Quality Control (QC) over radioisotope production processes. The Senior Analytical Radiochemist will support the implementation of Laboratory Information Management Systems (LIMS) and quality assurance procedures under 21 CFR 211, and ICH guidelines.
Method Development - Propose, develop, and conduct radiochemistry experiments to support design, scale-up, start-up and ongoing production of radioisotope manufacturing processes
- Develops and optimizes radiolabeling procedures and analytical methods
- Utilize a broad spectrum of analytical techniques i.e ICPMS, HPLC, iTLC HPGe.
- Perform development and validation of synthesis of RMX radiopharmaceuticals
- Troubleshoot radiochemical reactions and automation
- Execute engineering run and process validations
- Technical reviewer and drafting of validation documentation, associated Standard Operating Procedures (SOPs) and other quality documents
Quality Control Manager Responsibilities - Manage QC Team and delegate work appropriately. The QC Manager will also have bench top responsibilities.
- Execution and documentation of quality control testing of radiopharmaceutical drugs and API following cGMP guidelines (21 CFR 211)
- Analytical Testing methods e.g., identity testing, radiochemical purity, radionuclidic purity, endotoxin, sterility etc.
- Utilization of analytical equipment e.g. HPLC, iTLC, ICPMS, HPGE/Gamma Spec,GC
- Completing and maintaining appropriate documentation required by federal and state agencies associated with quality control and distribution of radiopharmaceutical drug products.
- Setup and maintain automated chemistry modules and laboratory equipment.
- Support RadioMedix development of radiochemical processes.
- Ensure Production and Quality Control methods are in conformity with cGMP.
- Assist in the development of procedures, test reports, operating procedures, and maintenance procedures for new or updated processing equipment.
Minimum Requirements - MS or Ph.D in Chemistry, Biology, Microbiology, and or life sciences.
- Radiochemistry experienced preferred
- Minimum 8-10 years in pharma experience/laboratory management and/or related pharma experience
- Thorough knowledge of cGMPs, GLPs, and pharma manufacturing
- Collaborates with cross functional teams including research, process development, quality assurance and quality control.
- Demonstrated proficiency in root cause analysis as applied in a pharma environment
- Excellent problem solving, communication, and decision-making skills
- Computer skills, and knowledge of document management/quality systems
- Experience working and communicating productively in a multidisciplinary team.
- Perform all work in compliance with site safety and radiation protection guidelines.
Job tags
Salary