Product Support Specialist

PRODUCT SUPPORT SPECIALIST, RCM Title Product Support Specialist Location Homebased with Travel (Any SOFIE Location) Department Radiopharmaceutical Contract Manufacturing (RCM) Reports To Director, Radiopharmaceutical Contract Manufacturing (RCM) OVERVIEW The Product Support Specialist will lead the maintenance of all analytical equipment used in the analysis of radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE's Operations and Technical Services teams, they will ensure that these radiopharmaceuticals quality control equipment are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 212). ESSENTIAL DUTIES AND RESPONSIBILITIES Provide maintenance support, troubleshooting, and maintenance of QC equipment (providing 'on-call' service, as needed). Act as liaison between facilities/maintenance groups and laboratory personnel to schedule preventative and corrective maintenance of equipment. Provide technical support and/or training for production staff at SOFIE sites, either remotely or on-site. This includes the training of site staff on maintenance schedules and necessary equipment. Install, qualify, and maintain laboratory equipment on site. Recommend and specify equipment purchased based on user requirements. Validate existing production or analytical methods on existing or new equipment. Author/Review/Execute qualification and/or validation protocols as needed. Author and manage change control related to QC equipment, as needed. Support the development of 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. Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development and radiopharmaceutical production. Communicate with other functions and external vendors regarding qualification issues and key operational objectives. 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. Identify compliance issues and process improvements related to the ongoing administration of QC equipment implementing effective resolutions. 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 equipment maintenance records and test/validation results. Write reports, presentations, and other documentation summarizing experimental/production data. Coordinate with the Radiopharmaceutical Contract Manufacturing team's activities to reach defined objectives. Other duties as assigned. QUALIFICATIONS Degree in chemistry, engineering or natural sciences preferred but will entertain applicants with relevant education and work experience. 4-years' experience in radiopharmaceutical manufacturing and QC in a GMP environment required. 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 is preferred. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. Strong problem solving and organizational skills. Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required. 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. Travel: up to 60% domestically.