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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 products' lifecycle. Executeproduct strategies through strong quality and scientific leadership related to technology transfers, global regulatory filing strategies, analytical method improvements, stability, product specifications and program improvements. 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. In collaboration with clients/partners, lead the authorship of the Annual Product Review reports, for commercial marketed products, and manage commitments to closure. Support the creation of Quality Target Product Profiles (QTPP) and product characterization and approve comparability assessments. Support process lifecycle and analytical lifecycle management programs/initiatives. Approve method transfer and validation protocols and reports. Support the development of product stability strategies. Approve stability 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 vaccines and nucleic acid products. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Experience with authoring or review of biological license applications (BLA)/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation (i.e., review cycle questions). Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances. • Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences, including facilitation and presentation skills. Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions, preferred. Experience in direct interaction with regulatory agencies/Boards of Health during inspections. Understanding of vaccine and nucleic acid 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
