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Job Description | RCM Product Specialist
Title | RCM Product Specialist
Location | Totowa, NJ (Remote Position)
Department | RCM
Reports To | Senior Director of RCM
Compensation | 80,000/yr
Overview
The RCM Product Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE within the itheranostic / FAPI Division. Working closely with SOFIE's pharmaceutical partners and internal staff, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211and 212).
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.
It is expected that the development of these protocols will involve both the application of scientific principles and rationales and adherence to regulatory requirements.
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.
Coordinate with the Radiopharmaceutical Contract Manufacturing team, Training team, and CMC teams' activities to reach defined objectives.
Troubleshoot production synthesis issues for Network.
Meet with key vendors to ensure timely deliverables
Liaise with contract partners (e.g., biotech and pharma) and Global Outreach team to support CMC deadlines.
Other duties as assigned
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.
Travel: up to 25% domestically.