VP – COO, Radiopharmaceutical CDMO Operations

Industry: Radiopharmaceuticals / CDMO / Nuclear Medicine

About the Role

A fast-growing CDMO focused on radiopharmaceuticals is seeking a Vice President & Chief Operating Officer to lead the launch and operational scale-up of its newly established manufacturing platform. This executive role reports directly to the President and will oversee all aspects of development, manufacturing, compliance, and commercial delivery.

The ideal candidate brings deep experience in the radiopharmaceutical or sterile injectable space, with proven leadership in building high-performing teams, scaling GMP-compliant operations, and driving customer-focused growth.

Key Responsibilities:

Strategic Leadership & Commercial Growth

• Define and implement the operating vision and roadmap for the radiopharmaceutical CDMO division.
• Identify and develop strategic partnerships in nuclear medicine and isotope supply to build market presence.
• Shape service offerings and operational models to position the CDMO competitively in the U.S. and global market.
• Drive contract acquisition and long-term client engagement.

Operations & Technical Oversight

• Oversee end-to-end development and manufacturing operations aligned with FDA regulations, including 21 CFR Part 11/211/212 and state-level nuclear requirements.
• Implement efficient systems for quality control, tech transfer, and continuous improvement across the product lifecycle.
• Lead capacity expansion, site readiness, and infrastructure development—including greenfield site build-outs if required.
• Ensure seamless execution of scale-up and commercial readiness activities.

Quality & Compliance

• Build a best-in-class Quality Management System (QMS) with strong SOPs, CAPA management, and regulatory audit preparedness.
• Ensure site-level adherence to radiopharma-specific regulations and guide teams through both internal and external inspections.
• Promote a culture of regulatory excellence and compliance transparency.

People & Organizational Development

• Recruit and lead a cross-functional team across operations, quality, regulatory, and business functions.
• Foster a culture centered around performance, collaboration, accountability, and client success.
• Develop internal governance, KPIs, and reporting structures to align with business objectives.

Financial Accountability & P&L Management

• Own the P&L for the CDMO division, optimizing cost, performance, and profitability.
• Design pricing models and support contract negotiations with biotech and pharma clients.
• Align operations with overall corporate strategy, working closely with executive leadership.

Ideal Candidate Profile

Qualifications:

• Bachelor’s degree in chemistry, engineering, nuclear sciences, or a related field (advanced degree preferred).
• 15+ years in pharmaceutical or biotech manufacturing, including leadership roles in CDMO or GMP-regulated environments.
• Extensive experience with sterile injectables, radiopharmaceutical production, or advanced therapeutic manufacturing.
• Proven success in launching and scaling manufacturing operations and building out high-performing teams.
• Strong regulatory knowledge (FDA, EMA, NRC), including quality systems, tech transfer, and GMP audit readiness.
• Commercial mindset with strong business development, client-facing, and contract negotiation experience.
• Excellent stakeholder management and cross-functional leadership skills.

Bonus Points For:

• Background in radiolabeling or nuclear medicine.
• Direct experience with facility design, site commissioning, or greenfield CDMO builds.
• Familiarity with early-phase to commercial launch in regulated drug development.
• Existing network within radiopharma or biotech supply chains.

What’s Offered:

• Executive-level role with influence over a transformative, high-growth CDMO platform.
• Competitive base compensation with performance incentives.
• Full benefits package including healthcare and retirement plans.
• Potential for equity or long-term incentives aligned with company performance.