Vice President, Operations

Radiomedix, Inc.•Humble, TX

3d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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 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)
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