Senior Director, Technology Management CMC Dossier Support - (Job Number: 0805878)

Senior Director, Technology Management CMC Dossier Support - (Job Number: 0805878) DescriptionCentocor, Inc. develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. The Senior Director, Technology Management & CMC Dossier Support is responsible for management and scientific leadership of the Technology Management & CMC Dossier Support groups within the Upstream Drug Substance Development & Technology Management area of Pharmaceutical Development Department. The Senior Director will provide scientific leadership within the Technology Management & CMC Dossier Support group consistent with corporate and R&D objectives and timelines. Senior Director will have technical responsibilities for several groups, including (a) provision of CMC Team Leadership for early & late development projects, (b) provision of integrated strategic plans for manufacturing & technology needs to late development & life cycle projects, and [c] review & approval of PD regulatory documents and provision of strategic & regulatory advice to PD lines. This individual will be responsible for the following: Management and scientific leadership of a diverse group of scientists, engineers, and technicians within the Upstream Drug Substance Development & Technology Management group to maintain and foster an efficient innovative organization with highly skilled personnel and modern technology. Encourage a team based collaborative culture with keen attention to customer needs. Direct and monitor technical programs to insure adherence to cGMP as appropriate, established timelines, and compliance with regulatory guidelines. Balance rapid development of new products with sound business decisions and risk management to create long term value. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. Direct responsibility for a multidisciplinary group of approximately 10 ' 15 professionals, of which about 5 will be at the Fellow level and 5 will be at the Associate Director level. Global impact will occur through domestic and international technology transfer activities to GBSC and CMOs, and through the preparation of CMC sections of electronic CTD filings and post-approval supplements for J&J biological products. PRINCIPAL RELATIONSHIPSDiscovery for APT & NMEs progressing toward developmentCell Banking, Gene Expression & Cell Therapies, and Cell Culture Process Development for progression of NMEsOther key customers including CMC RA, RDMO, CDTs, GBSC, and other J&J subsidiaries to progress their assets or provide technical assistance as needed Direct responsibility for a multidisciplinary group of approximately 10 ' 15 professionals, of which about 5 will be at the Fellow level and 5 will be at the Associate Director level. Global impact will occur through domestic and international technology transfer activities to GBSC and CMOs, and through the preparation of CMC sections of electronic CTD filings and post-approval supplements for J&J biological products. PhD preferred, or equivalent in education plus experience, in a biotechnology-related discipline Must have a minimum of 20 years in the pharmaceutical/biotech industry. Must have experience with industrial process development & technology transfer. Managerial & supervisory experience is required as is matrix management experience. Must have excellent written & verbal communication skills. Also required is experience with preparation of biologicals regulatory filings and post-approval changes. Must have proven ability to motivate & lead groups and teams to accomplish challenging goals. Apply Now