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Sr Expert, Science & Technology (Cell Therapy Formulation Development) (340964BR)


Development Manager



Cambridge, Massachusetts, United States

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>What You'll Be Doing:<br>The Senior Expert will lead and manage all drug product development efforts including but not restricted to: <br>• Formulation development, stability assessments, and technical management of external vendors. Routinely applies scientific/technical expertise to address complex drug product issues and actively support Technical Development strategies and goals by participating in cross-functional teams. Experience working with Quality systems. <br>• Knowledgeable of requirements associated with Drug Product for regulatory filings (i.e. extractables & leachables, container closure integrity, in-use stability, etc.).<br>• As a technical expert within the Technical Development organization, this individual will be accountable for Drug Production development activities for current and future Cell Therapy (CT) projects. Contribute to key technical activities including technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings. <br>• Deep expertise in the field of drug product considerations and regulatory requirements.<br>• Additionally, this role will contribute to interdisciplinary technical development initiatives for cell therapy projects. This role is expected to regularly interface with external partners, monitoring outsourced activities and ensuring deliverables according to Novartis standards. <br>• This role is expected to participate in global teams and contribute to overall development strategies. As a technical expert, he/she will actively participate in several technical forums. <br>• This role may have the opportunity to hire and manage technical associates in the future.<br>• The candidate will act as a subject matter expert for drug product considerations for cell therapies; interpreting and communicating results, evaluating data, draw relevant conclusions, and write reports and regulatory documents.<br>[#video#{#400,300#}#/video#]