Radiochemist

Job Description

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 requirementsProduction/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 teamMinimum 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

Location: 19705 Aldine Westfield Rd., Humble, TX 77338

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Full-time