Product Development Specialist

SOFIE•Totowa, NJ

23d•$80,000 - $90,000•Remote

About The Position

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).

Requirements

A degree in chemistry, engineering or natural sciences preferred but will still entertain applicants with relevant education and work experience.
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.
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.

Nice To Haves

PhD preferred.
Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification preferred.

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.
Write clear Standard Operating Protocols (SOPs) for these protocols.
Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory
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.