10! The number of projects you will participate in as the new Clinical Scientific Expert based at Novartis in East Hanover, New Jersey. As part of the Global Drug Development (GDD) team this role is critical in ensuring clinical trial data and Clinical Study Reports (CSR's) are of the highest quality throughout the life cycle of each project and ensure they are compliant.
Your responsibilities include, but are not limited to:
The Expert, Analytical Method Validation will support all activities to ensure timely and successful execution of method validation and transfer of methods. Helps with delivering quality products and services on time to all customers, internal and external. Assists with monitoring projects and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques. Involved in Laboratory planning to improve efficiency and throughput. Engage in projects to assure GMP beyond compliance.
* Perform the validation/qualification activities, including, Required Specifications, Qualification protocols and Reports, and Impact / Risk Assessments. * Initiate/support review of change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state. * Ensure the validated state of equipment, instruments, and systems supporting manufacturing is compliant with corporate policies and regulatory requirements. * Supports external teams in qualifying new and/or replacement equipment within the laboratory * Support execution of method qualification/development & optimization as governed by protocols and/or under the supervision of senior lab staff. * Support technology transfer activities at internally and externally, including transfer strategy, Support transfer protocol and reports, and risk assessments. Support Operations, Quality, Technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes. * Additionally, supports the maintenance of GMP and GLP systems and environment, as well as ensures that all safety requirements are met for the lab areas. * Assist with projects, manage own time to meet objectives