Job Description

Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for a skilled pharmaceutical industry professional with experience building teams in start-up environments to lead the Manufacturing Science and Technology (MS&T) function at our new Carlsbad site. As the Site Head MS&T, you will lead the site’s MS&T organization and activities, including Commissioning and Qualification (C&Q) activities. You will be responsible for maintaining and improving scientific oversight of the manufacturing processes and technical changes, technical knowledge and capabilities, and ensuring product and technical stewardship across functions at the Carlsbad Site. This role reports operationally into the Carlsbad Site Head and will be part of the Site Leadership Team. The role has functional reporting to both the Global MS&T and site Engineering organizations. Key Responsibilities: Ensure robust product stewardship for all products manufactured at the site, and end-to-end technical oversight of product manufacturing processes, at all stages of the commercial lifecycle. Set objectives and develop vision for the department. Manage the MS&T career path, succession planning, training program and career progression within the site. Drive a culture of quality and compliance across the MS&T team. Lead site activities related to technology transfer, change management and process improvement. Encourage the identification and implementation of new and innovative technologies. Propose business cases as needed. Ensure oversight of technical changes and lead end-to-end change control management related to relevant technical issues, working cross-functionally as required. Contribute to change records as impact assessor and action owner per Novartis change management requirements. Support deviation closure as a technical resource to ensure effective product impact assessment and root cause analysis. Own CAPAs as appropriate to ensure compliant and timely closure. Support excellence in manufacturing by setting standards and technical capability development and deployment. Identify and address process issues, maintaining the state of control of the products. Ensure technical excellence in operational start-up for new manufacturing equipment and areas. Ensure technical expertise for manufacturing equipment operation is taken into account for CAPEX projects. Lead execution and maintenance of site Validation Master Plan activities including the annual revalidation activities such as: aseptic processing, media fills, equipment requalification, and continuous improvement. Support C&Q activities related to the site build and initial start-up. Act as the interface for the site with the relevant Health Authorities for technical issues. Review and release regulatory proposals or information required for regulatory filings. Work with the other Site MS&T teams and networks of the relevant platform/cluster, driving reapplication of standard work processes, reapplication of best practices. Ensure that quality and compliance improvement and savings opportunities locally implemented are rapidly re-applied globally. Work collaboratively with functional management in the global MS&T organization as well as Technical Research and Development, to ensure that Technical Life Cycle Management (TLCM) projects are identified, prioritized and delivered with excellence. Essential Requirements: BSc degree in engineering, biology, chemistry, or related field or equivalent relevant experience. 7+ years’ experience in pharmaceutical MS&T roles with demonstrated experience driving quality, compliance and process improvement in an organization. Direct experience in an aseptic manufacturing setting. Expert in reviewing and writing technical reports. Fundamental understanding of standard pharmaceutical analytical testing. Desirable Requirements: Prior experience with radio pharmaceuticals is a plus. Additional relevant experience such as pharmaceutical formulation, process development, or manufacturing technology, is preferred. Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook . Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. Salary Range: $132,300.00 - $245,700.00 EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. #J-18808-Ljbffr Healthcare Businesswomen’s Association

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