RCM Product Specialist

Essential Duties And Responsibilities

• Develop protocols for the production and analysis of clinical-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.
• Provide 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.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
• Validate existing production or analytical methods on existing or new equipment.
• Collaborate with production radiochemists and quality control chemists as required to ensure successful protocol development and radiopharmaceutical production.
• Perform release testing, according to SOPs, on other materials (e.g., raw materials for 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 key vendors to ensure timely deliverables
• Liaise with contract partners (e.g., biotech and pharma) and Global Outreach team to support CMC deadlines.

Qualifications

• Degree in chemistry, engineering, or natural sciences preferred but will entertain applicants with relevant education and work experience.
• 3-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.
• Detail-oriented, accountable, patient, organized, and ability to 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.