Hiring: RCM Product Specialist Company: SOFIE Location: Totowa, NJ Job Posted Time: 2026-09-10 14:41:45 Employment Type: Contract / Remote Target Skills & Keywords : Microsoft Office, Revenue Cycle Management About the job Required Skills: •Job Description | RCM Product Specialist •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. 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. Experience with the use of automated synthesis modules and maintenance of automated modules required. •Demonstrated capacity 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. •Demonstrated capacity to work various shifts and weekends required. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!