Vice President/Chief Operating Officer - Radiopharmaceutical CDMO Operations

We are seeking an accomplished and strategic CDMO Leader to establish and lead our newly created Contract Development and Manufacturing Organization (CDMO). Reporting to the President, this role will lead a cross-functional team to ensure operational excellence, regulatory compliance (e.g., 21 CFR Part 211/212, 21 CFR Part 11), and radiation safety while fostering strong client relationships. The ideal candidate will have deep expertise in radiopharmaceutical development and manufacturing, with a proven track record of scaling operations, driving customer-centric growth, and ensuring regulatory compliance. This position will require travel to our Corporate Head Office in Yardley, PA and to our sites. This leader will play a critical role in defining the operational, commercial, and quality strategies to position the organization as a trusted partner for radiopharmaceutical and nuclear medicine clients. Key Responsibilities: Strategic Leadership and Business Development • Develop and execute the strategic vision, operational framework, and growth plan for the new CDMO organization. • Identify target markets, client segments, and service offerings to differentiate the CDMO in a competitive landscape. • Build strong relationships with isotope manufacturing, radiopharmaceutical and nuclear medicine partners to drive business development and secure long-term contracts. • Define and implement a scalable operating model that balances capacity, efficiency, and quality to meet client expectations. Operational Excellence and Manufacturing Oversight • Oversee end-to-end development and manufacturing operations, ensuring adherence to cGMP and other relevant regulatory requirements. • Implement robust systems, processes, and technologies to ensure operational efficiency and consistent product quality. • Lead capacity planning, resource allocation, and technology transfers to support product development and commercial manufacturing. • Drive continuous improvement initiatives across production, quality, and supply chain functions. Quality, Regulatory, and Compliance • Ensure all CDMO activities comply with applicable regulations (e.g., 21 CFR Part §211 and §212 (cGMP for PET Drugs), 21 CFR Part §11 (electronic records), and applicable state and nuclear regulatory requirements (e.g., NRC, state boards). • Oversee the development and maintenance of a robust Quality Management System (QMS), including SOPs, change control, and CAPA processes tailored to CDMO needs. • Support regulatory inspections and client audits, maintaining readiness and addressing findings effectively and efficiently. • Oversee QbD principles during construction of CDMO site(s) in the United States. Experience with greenfield CDMO construction projects preferred. Team Development and Organizational Growth • Build and lead a high-performing, multidisciplinary team across development, manufacturing, quality, and commercial functions. • Foster a collaborative, results-driven culture with a focus on innovation, accountability, and customer satisfaction. • Establish strong governance frameworks, reporting structures, and KPIs to monitor and optimize organizational performance. Financial and Commercial Accountability • Develop and manage P&L for the CDMO business, ensuring financial targets and operational efficiencies are met. • Oversee pricing models, contract negotiations, and revenue growth strategies to maximize profitability. • Collaborate with executive leadership to align CDMO growth objectives with overall corporate strategy. Qualifications and Experience: • Bachelor’s degree in nuclear pharmaceutical sciences, chemistry, engineering, or a related discipline (advanced degree preferred). • 15+ years of progressive experience in pharmaceutical/biotech development and manufacturing, including leadership roles within a CDMO or related organization. • Proven success in building and scaling CDMO operations, managing multi-site manufacturing, and driving business growth. • Deep knowledge of cGMP, regulatory frameworks (FDA, EMA), and fostering a culture of continuous quality improvement. • Strong commercial acumen with experience in business development, contract negotiation, and P&L management. • Demonstrated ability to build, lead, and inspire cross-functional teams in a fast-paced, dynamic environment. • Excellent communication and stakeholder management skills, with the ability to engage clients, partners, and internal teams effectively. Preferred Qualifications: • Experience with sterile injectables, biologics, or radiopharmaceutical manufacturing and extensive experience at a senior level within pharmaceutical manufacturing operations/technical operations. • Expertise in technology transfer, process scale-up, and commercial launch. • Strong network within the pharmaceutical and biotechnology sectors. At Jubilant Radiopharma, we champion an inclusive workplace that treasures diverse perspectives, experiences, and backgrounds. We are committed to building a diverse yet inclusive workplace that is representative of the marketplace and the communities in which the Company operates. Jubilant Radiopharma is proud to be an Equal Opportunityemployer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status or any other status protected by federal, state or local law. If qualified individuals with a disability need assistance in applying for this position, call Human Resources at 407-455-6700 informing us regarding the nature of your request and providing your contact information. We look forward to speaking with you about this exciting new career opportunity! Job Overview DATE POSTED : 01/11/25 LOCATION : Home Based COMPANY : Jubilant DraxImage, Inc. dba Jubilant Radiopharma FUNCTION : Manufacturing Apply tot his job