The Senior Laboratory Specialist, Tech Ops researches and develops new medicines for unmet medical needs through innovative medical science from inception, through clinical trials to commercialization. Assesses, monitors and ensures products meet clinical safety standards. Conducts sophisticated analysis, manages research information systems and technical documentation. May be involved in providing para-professional laboratory support for product testing after collection. Establishes relationship with regulatory authorities to establish and maintain registration licenses to sell products globally. Designs and implements business experimental processes to enable product research and development. Designs related integrated process and candidate/product team activities and directs technical and operational activities to ensure planned project outcomes, and enables portfolio prioritization, resource allocation, and risk management. Provides and contributes to project progression and reports, as required, to project or program committees for decision-making support. Leads teams in the development of program and project strategy, and lifecycle management planning. Develops systems to support dynamic portfolio management. Serves a key role in portfolio evaluation process. Drives initiatives across research and development units to create fully integrated strategies. Monitors and reports on portfolio status and proactively addresses and resolves issues. May design and develop manufacturing processes for new or existing products, taking into consideration problems inherent in the transfer of technology from research to manufacturing. Develops procedures for the economical mass production in cooperation with pilot-plant and production departments. Conducts tests and measurements throughout stages of production to determine control over applicable variables. As required, will need to operate within the current regulatory and compliance environments.
Main Responsibilities & Accountabilities
Qualifications & Experience Requirements