Principal Scientist, LCM Technical Lead

Job Title:  Principal Scientist, LCM Technical Lead

Location: Framingham, MA

About the Job

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.

Technical leadership of second-generation process improvement programs: Lead cross functional team of SMEs from USP, DSP and Analytical functions to establish process improvement strategy for one or more products and associated improvement projects, with emphasis on development of second-generation DS processes and associated control strategies, global regulatory submissions, and variation management for biologics drug substance processes. In consultation with MSAT Business Partners and DS function (USP, DSP) heads, you will develop process design criteria, process performance expectations and technical solution options to achieve those outcomes. You will lead a cross-functional team to select appropriate QbD strategies, process parameter risk assessments, application of prior knowledge, and justifying process parameter ranges to maximize operational flexibility during commercial manufacturing. You will prepare and present 2nd generation program technical strategies to the MSAT Technical Product Team and at governance forums for endorsement.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Process Innovation: Together with MSAT-DS and CMC-Development colleagues, evaluate and implement as appropriate innovative process architecture and process analytical technologies in 2nd generation programs. The process architecture innovation includes all DS process steps such as cell bank, seed train, production bioreactor, clarification, purification, filtration and DS storage and handling and its coupling with DP manufacturing, buffer and media preparations and associated testing control.

• Regulatory packages support: Develop proposal for CMC briefing package with supportive data and rationale for endorsement at MSAT governance forums. Lead cross func