Radiochemist

Roles/Deliverables

• Provide technical expertise to support the development of methodologies and procedures for chemical and radiochemical handling, of remote handling systems, and of radiochemical separations.
• Support the development and validation of analytical and radioanalytical methods and procedures that will be used to demonstrate Manufacturing and Quality Control (QC) over radioisotope and radiopharmaceutical production processes.
• Support the implementation of Laboratory Information Management Systems (LIMS) and quality assurance procedures under 21 CFR 211, and ICH guidelines.

Research

• Develop radiopharmaceuticals to support RadioMedix’s new product pipeline
• Propose, develop, and conduct experiments to support design, scale-up, start-up, and ongoing production of radioisotopes
• Develop and optimize radiolabeling procedures and analytical/radioanalytical methods
• Utilize a broad spectrum of analytical techniques/instrumentation (i.e., ICP-MS, ICP-OES, HPLC, iTLC, alpha/beta spectroscopy, gamma spectroscopy, and wet chemistry techniques)
• Develop associated analytical methods for characterization of radiolabeled products
• Perform development and validation of RMX radiopharmaceuticals
• Troubleshoot radiochemical reactions, radiochemical separations, and automated systems
• Execute engineering runs and process validations
• Technical writer and reviewer of validation documentation, Standard Operating Procedures (SOPs), and other quality documents
• Train team members in laboratory procedures and equipment
• Supervise the work of team members and assign tasks as needed
• Provide leadership and mentoring to team members
• Supper new product development, assist in management multiple projects, and contribute to team based investigations
• Ensure compliance with environment, safety, health, and quality program requirements
• Proficient in utilizing manipulators during production
• Proficient in synthesizer machines (i.e., Trasis All-in-one, mini-All-in-one) for new product development
• Provide training to team members in the use of synthesizer machines
• Manufacture radiopharmaceuticals including Ga68PSMA
• Calibrate manufacturing and quality control instrumentation
• Perform OOS investigations and CAPAs

Qualifications

• Ph.D. in Chemistry, Biology, Microbiology, and or life sciences.
• Radiochemistry experienced preferred
• Minimum 10 years’ experience in pharma/laboratory management and/or related pharma experience
• Thorough knowledge of cGMPs, GLPs, and pharma manufacturing
• Ability to collaborate 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.
• Strong organizational and communication skills including technical writing, presentation, and interpersonal skills