Senior MS&T Lead – Radiopharma Process Transfers

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 191,000 - 231,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Job summary

Scorpion Therapeutics in Indianapolis is seeking a senior MS&T leader to drive commercial manufacturing process ownership, tech transfer, and lifecycle management for radiopharmaceuticals. You will oversee end-to-end transfers, validation, and CPV across Stage 1–3, coordinating risk, documentation, and cross-functional collaboration.

The role requires extensive MS&T and regulatory experience, including GMP/ICH knowledge, CPT/APQRs, and a track record of leading teams through complex transfers

Qualifications

• BS/MS in relevant field (PhD preferred) or 12+ years MS&T with senior leadership.
• 10–15+ years MS&T/process development/technology transfer; 5+ years senior people management.
• Ownership of end-to-end transfers, process validation (Stages 1–3), CPV, APQRs in commercial GMP; radiopharmaceutical/sterile injectable experience preferred.
• Deep SPC/statistical capability; strong GMP/ICH knowledge; excellent communication and cross-functional influence.

Responsibilities

• Provide strategic/technical leadership for commercial manufacturing process ownership and tech transfer.
• Own end-to-end technology transfers to Indianapolis and related sites; plan, execute, document, and manage risk.
• Own MS&T process characterization and optimization; enforce VHP material compatibility as a transfer gate.
• Lead Process Validation lifecycle Stages 1–3 and CPV; manage SPC/control charts and investigations.
• Co-lead APQRs; manage MS&T CAPA from inspections.
• Lead post-launch deviation/complaint investigations and develop the MS&T team.
• Develop/defend CMC regulatory submissions and GMP documentation.

Skills

MS&T leadership

Process development

Technology transfer

People management

GMP/ICH knowledge

Education

BS/MS in relevant field

PhD preferred

Tools

Statistical analysis (SPC)

Quality systems (GMP/ICH)

Job description

Scorpion Therapeutics in Indianapolis is seeking a senior MS&T leader to drive commercial manufacturing process ownership, tech transfer, and lifecycle management for radiopharmaceuticals. You will oversee end-to-end transfers, validation, and CPV across Stage 1–3, coordinating risk, documentation, and cross-functional collaboration.

The role requires extensive MS&T and regulatory experience, including GMP/ICH knowledge, CPT/APQRs, and a track record of leading teams through complex transfers