Janssen Diagnostics is recruiting for a Sr. Scientist, operations product development and pilot manufacture, to be located in Raritan, NJ or PA.
Janssen Diagnostics is a division of Janssen Pharmaceutica R&D, a Johnson & Johnson Company with the primary objective of providing support in developing diagnostic solutions that create value and assist in the appropriate use of the products in development by Janssen Pharmaceutica in the areas of Infectious Diseases, Oncology, Immunology, Cardiovascular, Metabolic, and Neurosciences. Janssen Diagnostics incorporates the Veridex and Virco product lines, which provide innovative Diagnostics tools and Lab Testing Services to the oncology and infectious disease communities in a fast growing business in relation with Biomarkers and personalized medicine.
The Senior Scientist, operations product development and pilot manufacture, will lead development teams that have responsibility for delivering assays for our Contract Research Services, RUO and IVD products into manufacturing. The incumbent will direct groups and teams to accomplish tasks and project objectives including contract staff, Bachelor, Master, and possibly Ph.D. level scientists. The incumbent will direct the final stages of development of assays transferred from R&D, will design verification and validation procedures, direct and manage test executions, conduct design reviews, execute design transfers, and write reports. The incumbent will provide expertise and leadership critical to the definition and development of these products that ensures that product requirements including clinical claims, throughput, systems integration, and performance, and will work with the team to ensure a smooth transition into the factory occurs along with a successful launch.
The incumbent will create and manage complex development plans in the delivery of business results, and will anticipate needs and plans for the purchase, use and maintenance of laboratory equipment. The incumbent will follow best established procedures and provide recommendations to conduct development. The incumbent will coordinate and drive collaboration across the organization to assure completion of projects on time and within budget.
A Ph.D. degree in Chemistry, Biochemistry, or a related discipline, with at least 3 or more years of relevant industry experience or a Masters degree with 5 or more years or a Bachelors degree in a relevant field with 10 years of specific industry experience is required. A strong background in late stage product development in a Diagnostic environment is of importance. A strong knowledge of product design processes desired. Ability to influence at all levels is needed to demonstrate success in working within a matrix environment and leading multidisciplinary teams is required. Experience working collaboratively with external partners is highly desired. Experience working with legal, business development, quality and regulatory also highly desired. Excellent communication (verbal and written) and project management skills are critical. Full transparency, open mindedness and accountability are critical competencies. This position may require domestic and international travel. This position could be located in either PA or NJ.
North America-United States-New Jersey-Raritan
North America-United States-Pennsylvania-Huntingdon Valley
Janssen Research & Development, LLC. (6084)
Johnson & Johnson Family of Companies - 2 years ago
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