QC Chemist II

Job Description: QC Chemist II, Radiopharmaceutical Contract Manufacturing, NJ5 Title QC Chemist II Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.004 Overview: The QC Chemist II will perform analysis of diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Following SOFIE’s QA program and cGMP guidelines, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and EudraLex Volume 4). Essential Duties and Responsibilities ▪ Conduct required Quality Control analytical tests for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards. ▪ Prepare standards, samples, and mobile phase solutions for analytical methods. ▪ Ability to perform precise production visual inspection or laboratory appearance testing of finished product requiring 20/20 vision and accurate color differentiation (with or without reasonable accommodation) to assess product quality by evaluating color, clarity and absence of visible particulates for the drug product solution and evaluating attributes of the container closure system (e.g., cracks or chips in glass vials, creases in crimps, presence of stoppers, color of flip tops, etc.) in compliance with FDA, EudraLex and Rest of World guidance. ▪ Initiate deviation and OOS reports, lead root cause investigations ▪ Assist in the development, implementation, and validation of Quality Control analytical methods ▪ Follow protocols for the 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. ▪ Validate existing analytical methods on existing or new equipment. Follow method transfer protocols for clinical and commercial-grade radiopharmaceuticals. ▪ Write clear Standard Operating Protocols (SOPs) for QC protocols. ▪ Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements. ▪ Install, qualify, and maintain laboratory equipment on site. ▪ Collaborate with production radiochemists 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). ▪ Conduct environmental monitoring of environment and facilities. ▪ 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 test and validation results. ▪ Liaise with our contract partners as needed (e.g., biotech and pharma). ▪ Other duties as assigned. Qualifications ▪ Bachelor’s degree in Chemistry or natural science required with 2+ years of experience in analytical chemistry and instrumentation (qualification, troubleshooting and maintenance) required; a Master’s degree preferred. ▪ Experience in a GMP manufacturing environment is highly preferred. ▪ Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). ▪ 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 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. ▪ 20/20 natural or corrected vision and normal color vision, only for performance of visual inspection or appearance testing. ▪ Ability to work various shifts and weekends required.