Title
QC Chemist II
Location
NJ5-Totowa, New Jersey
Department
Radiopharmaceutical Contract Manufacturing

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 212).

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
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.
Ability to work various shifts and weekends required.