Title | Senior Product Development Specialist
Position Note | OPEN to any SOFIE locations
Location | Totowa, NJ
Department | Radiopharmaceutical Contract Manufacturing (RCM)
Reports To | Director, Radiopharmaceutical Contract Manufacturing (RCM)
OVERVIEW
The Senior Product Development Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE's pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 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.
o 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.
* Install, qualify, and maintain laboratory equipment on site.
* Validate existing production or analytical methods on existing or new equipment.
* Collaborate with other 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's activities to reach defined objectives.
* Liaise with our contract partners (e.g. biotech and pharma) to initiate, develop and complete critical projects.
* Collaborate with the SOFIE Clinical Development and Commercial Development teams to ensure cGMP compliance is maintained throughout all development activities.
* Independently outline and provide updates on the progress of various radiopharmaceutical contract manufacturing projects to both SOFIE and external stakeholders.
* Other duties as assigned.
QUALIFICATIONS
* Degree in chemistry, engineering or natural sciences preferred but will entertain applicants with relevant education and work experience. PhD Preferred.
* 5-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.
* 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 20% domestically.
