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MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Description Provides strategic guidance and acts as Quality approver for CMC related studies throughout the biological products' lifecycle. Execute/drive product strategies through strong quality and scientific leadership related to technology transfers, global regulatory filing strategies, analytical method improvements, stability, product specifications and program improvements. Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data. Negotiate plans with regulatory authorities and internal multi-functional teams. Oversee the development and approval of product specifications in collaboration with Clients and internal stakeholders. Monitor Product Quality Data, assess data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs. Provide guidance and approve process qualification/validation protocols and reports. Review and author sections of regulatory submissions, as directed. Support process lifecycle and analytical lifecycle management programs/initiatives. Approve method transfer and validation protocols and reports. Master's degree or higher in biochemistry, biology, regulatory sciences, engineering or a related pharmaceutical/biotechnology sciences field Minimum of 15 years of biotechnology industry experience, with minimum of 5 years in a CMC or product quality oversight role. Experience in biological product CMC is required. Comprehensive knowledge of cGMP and filing regulations, guidelines, practices, and trends pertaining to the manufacture and testing of biologics. Experience with authoring or review of biological license applications (BLA)/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation) Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions, preferred. Understanding of biological product development and manufacturing principles. Our client is a disruptive Life Sciences provider continuously advancing the science of biopharmaceutical manufacturing and development. Competitive base salary and overall compensation package Opportunity to own and develop specific product line Join a highly disruptive and innovative biopharmaceutical provider
