About RadioMedix RadioMedix is a Clinical and Commercial ready radiopharmaceutical biotechnology company focused on developing and manufacturing innovative targeted diagnostics and therapeutics. As a drug developer first, RMX integrates in-house R&D, manufacturing, and a CDMO model to advance both its internal pipeline and select strategic partnerships. Our state-of-the-art SPICA Center is a cGMP facility supporting early-phase through near-commercial radiopharmaceutical production under a 21 CFR 211-compliant quality system, with adherence to 21 CFR 212 where applicable. Position Overview The Vice President of Operations will lead all manufacturing and operational functions at RMX, ensuring efficient, compliant, and scalable execution across clinical and commercial radiopharmaceutical production. This role requires deep experience in GMP manufacturing, not a commercial or sales profile. The VP will work in close, day-to-day partnership with Quality Assurance and Operations to ensure operational excellence, facility reliability, and sustained inspection readiness. The ideal candidate brings operational rigor, quality-first execution, and the ability to scale processes from clinical through commercial manufacturing without compromising compliance, product quality, supply reliability, or execution speed . Key Responsibilities Operational Leadership 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 Manufacturing Excellence 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 Operations to 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) Technical Operations & Engineering 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. Quality & Compliance 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 Inspection Readiness & Regulatory Support 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 Process & Technology Transfer 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 People Leadership 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 Strategic Operations 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 Qualifications Required 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. Preferred 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 lJaVzLNnbM