Principal Scientist, Drug Substance CMC-LMC
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Position Title: Principal Scientist, Drug Substance LCM-CMC Leader, SC-MSAT
Location: US, France or Belgium
WHO YOU ARE:
As the Drug Substance Process LCM-CMC (Life-Cycle Management - Chemistry Manufacturing Controls) 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 Innovation team in the Drug Substance function, a major function of within Global Specialty Care Manufacturing Science and Analytical Technology (SC-MSAT) department. SC-MSAT 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, working closely with CMC-Development colleagues in R&D.
The function is also responsible for implement product control strategies, provide technical support to manufacturing sites for significant deviations and drive 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 SC-MSAT department is comprised of 400 scientists and engineers located in 5 countries. 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 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 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.
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 functional team effort to prepare Process development & control strategy sections, comments resolution and responses to agencies for briefing packages and final dossier. Provide technical support during PAI for relevant dossier sections.
Pipeline support- Member of CMC team for specific group of new products in commercial process development. Enable fast pace of CMC development of new products to launch by providing stage appropriate input such as manufacturability, risk assessment, control strategy, process validation, dossier review and post approval change management strategies during development of new biological products.
CMC practices for Stage I Validation: Partner with managers and team leaders within DS and Analytical, CMC Development, and Regulatory Affairs to influence Sanofi practices for stage I validation and enable simplification of workflow, use of prior knowledge and appropriate risk assessments and PAR studies. Engage with external organizations (ICH, PDA, BPOG, etc.) to influence the future direction of CMC practices in this area. Adopt best practices in simplifying relevant dossier sections and contribute to its improvements. Participate in industry conferences to increase Sanofi’s visibility in the biopharmaceutical community.
Team leadership: Work with MSAT DS and Analytical function heads to form 2nd generation process development sub team. Provide and ask for feedback from team members routinely and share with respective managers. As a member of Process Innovation group, exchange on best practices and learnings across 2nd generation programs.
BS with 10+ years of professional experience OR MS with 7+ years of professional experience OR PhD with 5+ years of professional experience
Degree in chemical engineering, biotechnology, biological sciences, or other relevant discipline
Minimum of 4 years of hands-on experience in process development in either upstream or downstream, writing of sections in regulatory briefing packages or dossier and associated discussions with agencies
Minimum of 2 years’ experience working in a cross-functional matrix team
Process development experience with mammalian expressed proteins
Knowledge of all steps of Drug Substance process (cell culture, fermentation, chromatography, filtration for example) and associated raw materials, process equipment technologies and analytical technologies
Some experience in leading cross-functional teams
Some experience in contributing to establishing control strategy and comparability strategy for biologics DS processes
Understanding of biologic product attributes, analytical methods in support of process design, control, and comparability
Understanding of ICH guidelines in establishing process life cycle management strategies
Some experience in technology transfer, scale-up, process validation and complex technical investigation in manufacturing
Knowledge of manufacturability requirements including GMP, raw materials, resins and SUTs, process architecture in plants, cadence, cost of goods
Knowledge of drug product requirement for drug substance
Digital skills including use of productivity and collaboration tools, scientific data analysis, statistical and other tools for design of experiments, & process models for establishing design space and advanced process controls
Proven Communication skills, oral and writing about complex topics to a variety of audiences internally and externally
Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site international teams
Approximately 15% travel for site visits, conferences and training and contract development organization relationship management.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.