Overview

Job DescriptionJob DescriptionRadiochemist RadioMedix Inc., a Biotechnology Company headquartered in Houston, Texas, is seeking an experienced Radiochemist to work in our SPICA Facility. The successful candidate will play a key role in process development, radioisotope and radiopharmaceutical manufacturing, and life-cycle management of GMP products. This position will focus on high-priority projects at RadioMedix that will be integral to upcoming clinical drug 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 Radiochemist will provide technical expertise to support the development of methodologies and procedures for chemical and radiochemical handling, remote handling systems, and radiochemical separations. They will also 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. The Radiochemist will support the implementation of Laboratory Information Management Systems (LIMS) and quality assurance procedures under 21 CFR 211, and ICH guidelines.ResearchDevelop radiopharmaceuticals to support RadioMedix's new product pipelinePropose, develop, and conduct experiments to support design, scale-up, start-up, and ongoing production of radioisotopesDevelop and optimize radiolabeling procedures and analytical/radioanalytical methodsUtilize 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 productsPerform development and validation of RMX radiopharmaceuticalsTroubleshoot radiochemical reactions, radiochemical separations, and automated systemsExecute engineering runs and process validationsTechnical writer and reviewer of validation documentation, Standard Operating Procedures (SOPs), and other quality documentsTrain team members in laboratory procedures and equipmentSupervise the work of team members and assign tasks as neededProvide leadership and mentoring to team membersSupper new product development, assist in management multiple projects, and contribute to team based investigationsEnsure compliance with environment, safety, health, and quality program requirementsProduction/ManufacturingProficient in utilizing manipulators during productionProficient in synthesizer machines (i.e., Trasis All-in-one, mini-All-in-one) for new product developmentProvide training to team members in the use of synthesizer machinesManufacture radiopharmaceuticals including Ga68PSMACalibrate manufacturing and quality control instrumentationPerform OOS investigations and CAPAsOpportunity for growthCross-functional work to support current and new products as neededPotential to a drug product manufacturing teamMinimum RequirementsPh.D. in Chemistry, Biology, Microbiology, and or life sciences.Radiochemistry experienced preferredMinimum 10 year's experience in pharma/laboratory management and/or related pharma experienceThorough knowledge of cGMPs, GLPs, and pharma manufacturingAbility 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 environmentExcellent problem solving, communication, and decision-making skillsComputer skills, and knowledge of document management/quality systemsExperience working and communicating productively in a multidisciplinary team.Perform all work in compliance with site safety and radiation protection guidel