Director, MS&T Radiopharmaceutical Operations

Responsibilities:

• Provide strategic/technical leadership for commercial manufacturing process ownership, technology transfer, process validation (Stages 1–3), CPV, SUPAC (post-approval changes), and lifecycle management at the Indianapolis radiopharmaceutical manufacturing site.
• Own end-to-end technology transfers (post R&D/CMC to Indianapolis, IndianapolisCDMO, reverse transfers), including planning, execution, documentation, risk management, and transfer plans; lead late Phase 2/Phase 3 and commercial-scale transfers.
• Own MS&T process characterization, optimization (yield, cycle time, robustness, operator safety), and enforce VHP material compatibility as a transfer gate.
• Own Process Validation lifecycle:
  Stage 1 (design space/CPPs/CQAs knowledge capture), Stage 2 (PPQ; protocol/execution/statistics; ICH Q8–Q12 reporting), Stage 3 (CPV; SPC/control charts/trending; capability and investigations).
• Co-lead APQRs; lead regulatory inspection readiness (FDA/EMA), and manage MS&T-related CAPA from inspections.
• Lead post-launch deviation/complaint investigations (root cause + CAPA) and develop the MS&T team.
• Develop/defend CMC regulatory submissions and author/approve GMP documentation.

• Ensure radiochemistry/radiolabeling short half-life transfers, containment, and regulatory rigor; integrate radiation safety and time-sensitive QC release coordination.

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

• Health, wellbeing, and financial protection benefits; paid time off (details vary by location/eligibility).
• Compensation range:
  Indianapolis $190,989–$231,434.