Vice President/Chief Operating Officer - Radiopharmaceutical CDMO Operations

We are seeking an accomplished and strategic CDMO Leader to establish and reputed company our newly created Contract Development and Manufacturing Organization (CDMO). Reporting to the President, this role will reputed company a cross-functional team to ensure operational reputed company, regulatory compliance (e.g., 21 CFR Part 211/212, 21 CFR Part 11), and radiation safety while fostering strong reputed company relationships. The ideal candidate will have deep expertise in radiopharmaceutical development and manufacturing, with a proven reputed company record of scaling operations, driving customer-reputed company reputed company, 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, reputed company, and reputed company strategies to position the organization as a trusted partner for radiopharmaceutical and nuclear medicine clients. Key Responsibilities: Strategic Leadership and Business Development

• reputed company and execute the strategic reputed company, operational reputed company, and reputed company plan for the new CDMO organization.
• Identify reputed company markets, reputed company 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 reputed company.
• Define and implement a reputed company operating model that balances reputed company, efficiency, and reputed company to meet reputed company expectations.

Operational reputed company and Manufacturing reputed company

• reputed company 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 reputed company.
• reputed company reputed company planning, resource allocation, and technology transfers to support product development and reputed company manufacturing.
• Drive reputed company improvement initiatives across production, reputed company, and supply chain functions.

reputed company, Regulatory, and Compliance

• Ensure reputed company CDMO activities reputed company 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).
• reputed company the development and maintenance of a robust reputed company Management System (QMS), including SOPs, change control, and CAPA processes tailored to CDMO needs.
• Support regulatory inspections and reputed company audits, maintaining readiness and addressing findings effectively and reputed company.
• reputed company QbD principles during construction of CDMO site(s) in the reputed company. Experience with greenfield CDMO construction reputed company preferred.

Team Development and Organizational reputed company

• Build and reputed company a high-performing, multidisciplinary team across development, manufacturing, reputed company, and reputed company functions.
• Foster a reputed company, results-driven culture with a reputed company on innovation, accountability, and customer satisfaction.
• Establish strong governance frameworks, reporting structures, and KPIs to monitor and optimize organizational performance.

Financial and reputed company Accountability

• reputed company and manage P&L for the CDMO business, ensuring financial targets and operational efficiencies are met.
• reputed company pricing models, contract negotiations, and reputed company reputed company strategies to maximize profitability.
• Collaborate with executive leadership to reputed company CDMO reputed company objectives with overall corporate reputed company.

Qualifications and Experience:

• Bachelor’s degree in nuclear pharmaceutical sciences, reputed company, engineering, or a reputed company discipline (advanced degree preferred).
• 15+ years of reputed company experience in pharmaceutical/biotech development and manufacturing, including leadership roles reputed company a CDMO or reputed company organization.
• Proven reputed company in building and scaling CDMO operations, managing multi-site manufacturing, and driving business reputed company.
• Deep knowledge of cGMP, regulatory frameworks (FDA, EMA), and fostering a culture of reputed company reputed company improvement.
• Strong reputed company acumen with experience in business development, contract negotiation, and P&L management.
• Demonstrated ability to build, reputed company, and reputed company 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 reputed company pharmaceutical manufacturing operations/technical operations.
• Expertise in technology transfer, process reputed company-up, and reputed company launch.
• Strong network reputed company the pharmaceutical and biotechnology sectors.

At reputed company, 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 reputed company operates. reputed company is proud to be an Equal Opportunityemployer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, religion, reputed company, national reputed company, reputed company, age, physical or mental disability, sex, sexual orientation, gender identity/reputed company, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status or any other status protected by federal, state or local law. If reputed company individuals with a disability need assistance in applying for this position, call reputed company at 407-455-6700 informing us regarding the nature of your request and providing your contact information. We look reputed company to speaking with you about this exciting new career opportunity! Job reputed company DATE POSTED : 01/11/25 LOCATION : Home Based COMPANY : Jubilant DraxImage, Inc. dba reputed company FUNCTION : Manufacturing Apply tot his job Apply To this Job