Our client is a Biotechnology Company headquartered in Houston, Texas, seeking an experienced Senior Radiochemist II to work its newly constructed GMP radiopharmaceutical manufacturing facility. The successful candidate will be critical in R&D, regulatory strategy, method development, and GMP investigations. The focus of the position will be to focus on high-priority projects that will be integral to upcoming clinical trials. This is a newly created position with the potential for significant growth.

Roles/Deliverables

The Senior Analytical Radiochemist will provide technical expertise to support the development of analytical methods and procedures that will be used to demonstrate Quality Control (QC) over radioisotope manufacturing processes and clinical dose preparation. This position will also draft documents related to regulatory filings for CMC of DMFs, INDs, NDAs, and FDA/EMA communications. The Senior Analytical Radiochemist II will support the implementation of Laboratory Information Management Systems (LIMS) and quality assurance procedures under 21 CFR 211 and ICH guidelines.

Research

• Characterize radiolabeled drug products, troubleshoot the process, and interpret data.
• Optimize formulations and radiolabeling processes.
• Utilize a broad spectrum of analytical techniques, i.e., ICPMS, HPLC, TLC, and HPGe.
• Develop associated analytical methods for the characterization of radiolabeled products
• Perform development and validation of synthesis of the novel PET/SPECT and radiotherapeutic drugs
• Troubleshoot radiochemistry using manual and automated approaches
• Draft protocols for engineering run and process validations
• Drafting of validation documentation, associated Standard Operating Procedures (SOPs), and other quality documents

Opportunity for growth

• Opportunity to grow the R&D and manufacturing team with room for advancement in the company

Minimum Requirements

• Ph.D. in Chemistry or Organic Chemistry.
• Radiochemistry experience is required.
• Minimum 5-10 years of pharma experience/laboratory experience/ GMP experience
• Thorough knowledge of cGMPs, GLPs, and pharma manufacturing
• Demonstrated auditing and corrective proficiency
• 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.
• Radiation Safety
• Area radiation surveys and contamination control
• Radioactive waste management
• Ensure functionality and calibration of all radiation safety equipment, such as survey meters.
• Perform radiation safety duties and audits to ensure every area complies with all regulations and requirements.
• Ensure radioprotection standards are respected.
• Provides essential support and supervision for ensuring calibration of all radiation instrumentation
• Ensures understanding of radiation safety and risk management among staff
• Perform radiation safety duties to ensure compliance with all regulations.
• Assess the nuclear waste characteristics of the group’s chemical processes to support regulatory and waste classification exercises.