Job Description | Product Development Specialist

Title | Product Development Specialist
Location | Various
Department | Radiopharmaceutical Contract Manufacturing (RCM)
Reports To | Director, Radiopharmaceutical Contract Manufacturing (RCM)

Overview
The 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.
Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific
procedures relative to their job functions.
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).
Other duties as assigned.
QUALIFICATIONS
A degree in chemistry, engineering or natural sciences preferred but will still entertain applicants with relevant education
and work experience. PhD preferred.
3-years' experience preferred in radiopharmaceutical manufacturing and QC in a GMP or academic environment
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 required.
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 preferred.
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 25% domestically.