Vice President, Operations

• Lead day-to-day operations across Manufacturing, Materials Operations, and Facility functions at SPICA
• Be physically present on-site to drive execution, resolve issues in real time, and maintain operational visibility
• Drive execution of clinical and commercial production schedules with precision and accountability
• Ensure seamless coordination across MFG,QA, QC, R&D, Facilities and Engineering
• Build and apply operational discipline, ownership, and accountability across teams
• Operational risk management and business continuity planning

• Long-term capacity planning & capital investment strategy to support commercial-scale operations
• End-to-end operations and supply strategy (including radiopharmaceutical logistics and isotope supply
• Financial accountability, including COGs, and where applicable, P&L responsibility
• Oversee radiopharmaceutical manufacturing (diagnostic and therapeutic), including generator-based and isotope handling processes
• Work closely with Operationsto ensure equipment reliability, facility uptime, and timely resolution of technical issues
• Ensure consistency, reliability, and readiness for scale-up from clinical to commercial manufacturing
• Optimize production workflows, batch success rates, and turnaround times
• Implement data-driven performance metrics (e.g., batch success, deviations, throughput)

• Oversee operational readiness, maintenance, and execution of equipment qualification activities in alignment with QA-approved validation strategies and protocols for:
  • Hot cells, isolators, and synthesis modules
• Support tech transfer and scale-up of new radiopharmaceutical products.

• Operate in close partnership with Quality Assurance as an independent function governing the quality system
• Ensure operations execute in accordance with QA-approved quality systems aligned with 21 CFR 211 and 212 requirements
• Drive a culture of right-first-time execution, deviation reduction, and operational excellence
• Ensure timely and thorough investigation support for deviations, CAPAs, and quality events

• Ensure manufacturing operations maintain a continuous state of execution readiness for regulatory inspections
• Support and actively participate in FDA inspections (PAI, routine, for-cause)
• Partner with QA and Regulatory to support IND, NDA, and ANDA filings with operational and CMC input

• Lead execution of tech transfer activities for internal pipeline and CDMO partners into GMP
• Execute process demonstration runs (PDRs), PPQ batches in alignment with approved protocols
• Collaborate cross-functionally to ensure processes are scalable, robust, and suitable for GMP manufacturing

• Build, mentor, and retain a high-performing operations team
• Set clear expectations for execution, accountability, and communication
• Ensure manufacturing teams are trained and compliant with applicable procedures and requirements
• Foster a culture of accountability, ownership, and continuous improvement
• Address performance gaps directly and constructively

• Partner with executive leadership to align operations with company growth strategy and commercial readiness
• Support expansion of CDMO capabilities while maintaining RMX’s identity as a drug developer
• Evaluate and implement systems, tools, and infrastructure to support scaling
• Drive long-term manufacturing strategy, including capacity planning and supply chain robustness for commercial products

• Bachelor’s degree in Chemistry, Biology, Engineering, or related field (advanced degree preferred)
• 12–15+ years of experience in pharmaceutical or radiopharmaceutical manufacturing
• Proven leadership experience in GMP operations
• Deep understanding of:
  • 21 CFR 211
  • 21 CFR 212
  • NRC / Agreement State regulations
• Hands-on manufacturing leadership experience
• Demonstrated success in:
  • Inspection readiness and FDA interactions
  • Tech transfer and process scale-up
  • Cross-functional leadership in regulated environments
• Deep understanding of:
  • Radiochemistry and radiolabeling processes
  • Aseptic manufacturing
  • Short half-life production logistics
• Familiarity with isotopes such as (e.g., Pb-212, Ac-225, Ga-68, Cu-64.etc.

• Radiopharmaceutical experience (Ga-68, Pb-212, or similar isotopes strongly preferred)
• Experience in a CDMO and/or clinical-stage biotech environment
• Experience working closely with Operations in GMP facilities (equipment, utilities, facility systems)
• Familiarity with short-lived isotope logistics and time-sensitive manufacturing

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