Principal Scientist, LCM Technical Lead
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About The Position
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. As the DS Process LCM-CMC leader, you will be responsible for managing second-generation process development of commercialized biologics to improve robustness, lower cost of goods and minimize capital investments. Implementation of second-generation processes is one of the top performance enablers for our biologics manufacturing network. You will drive external engagement for process technology innovation in Drug Substance processes in collaboration with other technical leaders and its adoption in your programs. You may also represent DS function in CMC teams of new products to enable pace of CMC development cycles for new products by providing inputs such as manufacturability, processing platforms including material and equipment. You will be a member of Process Engineering and Innovation team in the Drug Substance function, a major function of within the Recombinant Mammalian Platform Drug Substance Platform within Global MSAT. Our department is responsible for product stewardship of all Biologics based Specialty Care products including leading technology transfer and validation of new processes and major Life Cycle Management changes as well as working closely with CMC-Development colleagues in R&D. The function is also responsible for implementation of product control strategies, provides technical support to manufacturing sites for significant deviations and drives process and product life cycle management improvements for process robustness and yields, reducing cycle times and discard rates to enable top decile performance and productivity relative to our peers. The scope of Drug Substance function includes up to 20 commercial and late-stage products manufactured at internal and external biologics DS sites. The MSAT department is comprised of 1300 scientists and engineers located in countries across the world. The Drug Substance function within SC-MSAT has state of art laboratories and pilot facilities in the US at Framingham, Belgium at Geel and France at Lyon. The Process Engineering and Innovation group, within Drug Substance function, is comprised of technical experts who leads multiple 2nd generation process development programs based on innovative platforms to have transformational impact on industrial performance of our manufacturing sites.
