Greater Cambridge Area
Responsible for global regulatory affairs for manufacturing and product development. Responsible for developing and advocating science based positions for a number of global issues with regard to government regulation of biopharmaceutical products
Responsible for regulatory affairs, quality assurance, quality control, drug surveillance, and pharmacology/toxicology including a staff of about 400 with multiple development and commercial manufacturing facilities.
Responsible for coordination of research across three products related Offices of Vaccines, Blood, and Therapeutics which includes 9 research divisions and approximately 300 research staff. Manages the Center advisory committee programs, peer review process for research scientists, and represents the Center as an expert for biotechnology quality issues.
Supervise the research and regulatory activities of the senior staff, postdoctoral fellows, and technicians in the laboratory. Plan the budget, allocate space and resources for the laboratory. Direct supervision of the research activities of postdoctoral fellows and technicians carrying out basic research in second messenger regulation and interactions of small ligands with membrane transport proteins. These studies address the regulation of hormone sensitive adenylyl cyclase, facilitated glucose transporters, and the multidrug transporter P-glycoprotein. Administrative supervision of research programs that are being conducted by independent staff investigators in the Laboratory. These programs encompass the areas of oligonucleotide synthesis and developmental biology. Supervision and management of facility for the production and purification of synthetic peptides, use of peptides for antibody development, and separation and sequencing of biologically relevant proteins and peptides. Review INDs, serve on licensing committees, and lead inspections of biotechnology manufacturing facilities. Train inspectors for the cGMP inspections for biotechnology manufacturing facilities and serve as a biochemical expert on working groups and task force at the Center and FDA. Oversee training and regulatory activities of staff in the laboratory regarding growth factors, monoclonal antibodies, synthetic peptides, and other products.
Responsibility for a staff of 240 in four product research divisions, one clinical trial review division, and an application division. Responsible for supervising the regulatory and research activities of product related divisions of monoclonal antibodies, cellular and gene therapy, monoclonal antibodies, and hematologic products; the clinical trial design and analysis division, and the applications division.