SOFIE
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Product Development Specialist
role at
SOFIE .
2 days ago – Be among the first 25 applicants.
Looking for a role where your expertise can make an immediate difference? Step into a position that allows you to lead groundbreaking product development in a rapidly growing industry.
Job Description Title:
Product Development Specialist
Location:
Remote
Department:
Radiopharmaceutical Contract Manufacturing (RCM)
Pay:
$80,000-$90,000/YR (based on experience and education)
Overview The Product Development Specialist will lead the development, implementation, and validation of manufacturing and analytical methods for 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 in accordance with cGMP standards.
Apply scientific principles, rationales, and regulatory requirements to develop protocols.
Write clear Standard Operating Protocols (SOPs) for these protocols.
Review existing SOPs and suggest logical modifications based on scientific rationales and 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.
Maintain laboratory equipment on site, including installation, qualification, and ongoing maintenance.
Validate existing production or analytical methods on existing or new equipment.
Collaborate with production radiochemists and quality control chemists to ensure successful protocol development and radiopharmaceutical production.
Perform release testing according to SOPs on raw materials and other materials for radiopharmaceutical production.
Maintain 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 and production data.
Coordinate with the Radiopharmaceutical Contract Manufacturing team’s activities to reach defined objectives.
Liaise with contract partners (e.g., biotech and pharma).
Other duties as assigned.
Qualifications
A degree in chemistry, engineering, or natural sciences (PhD preferred).
3‑year preferred experience 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 automated synthesis modules and their maintenance.
Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification.
Proficient in the MS Office Suite.
Detail‑oriented, accountable, patient, organized, and able to work in a team environment with minimum supervision.
Strong technical writing skills.
Excellent organizational skills.
Ability to work various shifts and weekends.
Travel up to 25% domestically.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Product Management and Marketing
Industries Pharmaceutical Manufacturing
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Product Development Specialist
role at
SOFIE .
2 days ago – Be among the first 25 applicants.
Looking for a role where your expertise can make an immediate difference? Step into a position that allows you to lead groundbreaking product development in a rapidly growing industry.
Job Description Title:
Product Development Specialist
Location:
Remote
Department:
Radiopharmaceutical Contract Manufacturing (RCM)
Pay:
$80,000-$90,000/YR (based on experience and education)
Overview The Product Development Specialist will lead the development, implementation, and validation of manufacturing and analytical methods for 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 in accordance with cGMP standards.
Apply scientific principles, rationales, and regulatory requirements to develop protocols.
Write clear Standard Operating Protocols (SOPs) for these protocols.
Review existing SOPs and suggest logical modifications based on scientific rationales and 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.
Maintain laboratory equipment on site, including installation, qualification, and ongoing maintenance.
Validate existing production or analytical methods on existing or new equipment.
Collaborate with production radiochemists and quality control chemists to ensure successful protocol development and radiopharmaceutical production.
Perform release testing according to SOPs on raw materials and other materials for radiopharmaceutical production.
Maintain 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 and production data.
Coordinate with the Radiopharmaceutical Contract Manufacturing team’s activities to reach defined objectives.
Liaise with contract partners (e.g., biotech and pharma).
Other duties as assigned.
Qualifications
A degree in chemistry, engineering, or natural sciences (PhD preferred).
3‑year preferred experience 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 automated synthesis modules and their maintenance.
Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification.
Proficient in the MS Office Suite.
Detail‑oriented, accountable, patient, organized, and able to work in a team environment with minimum supervision.
Strong technical writing skills.
Excellent organizational skills.
Ability to work various shifts and weekends.
Travel up to 25% domestically.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Product Management and Marketing
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr