Sr. Radiochemist

Essential Duties And Responsibilities

• Lead the development of protocols for the production and analysis of clinical/commercial-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards.
• Write clear Standard Operating Protocols (SOPs) for these protocols.
• Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements.
• Serve as lead technical support and/or training for production staff at SOFIE sites, either remotely or on-site.
• Write corporate exception reports and other regulatory documents, such as risk assessments, change controls, etc.
• Conduct production or quality control analytical tests for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards.
• Install, qualify, and maintain laboratory equipment on site.
• Validate existing production or analytical methods on existing or new equipment.
• Lead the collaboration with other production radiochemists and quality control chemists as required to ensure successful protocol development and radiopharmaceutical production.
• Maintain all qualification and validation requirements for entering ISO classified areas.
• Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.
• Maintain accurate radiopharmaceutical production records and test/validation results.
• Write reports, presentations, and other documentation summarizing experimental/production data.
• Cook up with the Radiopharmaceutical Contract Manufacturing team’s activities to reach defined objectives.
• Liaise with our contract partners (e.g. biotech and pharma).

Qualifications

• Degree in chemistry, engineering or natural sciences preferred but will entertain applicants with relevant education and work experience.
• PhD preferred.
• 5 years’ experience preferred in radiopharmaceutical manufacturing and QC in a GMP or academic environment.
• Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.).
• Experience with the use of automated synthesis modules and maintenance of automated modules required.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
• Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification preferred.
• Efficient in the use of MS Office Suite required.
• Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required.
• Strong technical writing skills required.
• Excellent organizational skills required.
• Ability to work various shifts and weekends required.