Director, Radiopharmaceutical Development Quality

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Development Quality leader to oversee quality for development-stage radiopharmaceutical programs, aligning with ICH, FDA, EMA, and USP requirements.

The role partners with cross-functional teams to implement fit-for-purpose GxP expectations, manage short half-life manufacturing quality topics, and prepare for regulatory interactions while leading a dedicated team.

Qualifications

• 10+ years progressive pharmaceutical/biotech/radiopharmaceutical quality experience with development-stage GMP depth.
• 7+ years leading/developing quality teams; experience building new quality functions.
• Direct experience with IND/CTA; NDA/BLA quality strategy; CTD Module 3 oversight/interaction with authorities.

Responsibilities

• Provide GMP quality oversight for development-stage radiopharmaceutical programs.
• Oversee short half-life manufacturing quality topics and related controls.
• Coordinate with Radiation Safety Officer on hot-cell qualification and dose calibrator validation.
• Lead Development Quality team; coaching, workload management and capability building.
• Represent Development Quality in stage-gates and governance forums; manage quality risk escalations.
• Support regulatory interactions/inspections as the Development Quality representative.

Skills

GMP quality oversight

Radiopharmaceutical quality

Quality leadership

Cross-functional collaboration

Regulatory agency interaction

IND/CTA regulatory submissions

Education

MS/PharmD/PhD in pharmacy/chemistry/radiochemistry

Bachelor's with equivalent experience

Job description

Scorpion Therapeutics seeks a Development Quality leader to oversee quality for development-stage radiopharmaceutical programs, aligning with ICH, FDA, EMA, and USP requirements.

The role partners with cross-functional teams to implement fit-for-purpose GxP expectations, manage short half-life manufacturing quality topics, and prepare for regulatory interactions while leading a dedicated team.