Radiochemist

Radiomedix•Houston, TX

16d•Onsite

About The Position

Radiochemist RadioMedix Inc., a Biotechnology Company headquartered in Houston, Texas, is seeking an experienced Radiochemist to work in its newly constructed GMP radiopharmaceutical manufacturing facility. The successful candidate will play a key role in R&D, 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, of remote handling systems, and of 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. 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 Production/Manufacturing 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 Opportunity for growth Opportunity to grow the R&D team with room for advancement in the company Cross-functional work to support current and new products as needed Potential to a drug product manufacturing team

Requirements

Ph.D. in Chemistry, Biology, Microbiology, and or life sciences.
Radiochemistry experienced preferred
Minimum 10 year’s 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

Responsibilities

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.
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
Cross-functional work to support current and new products as needed