Principal Scientist, LCM Technical Lead

Job Title:  Principal Scientist, LCM Technical Lead

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 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.

About You

BASIC QUALIFICATIONS:

• Degree in chemical engineering, biotechnology, biological sciences, or other relevant discipline

• BS with 10+ years of professional experience or MS with 7+ years of professional experience or PhD with 5+ years of professional experience

• Minimum of 5 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 4 years’ experience working in a cross-functional matrix team

PREFERRED QUALIFICATIONS:

• 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

• Experience in leading cross-functional teams is preferred

• Experience in contributing to establishing control strategy and comparability strategy for biologics DS processes is a must

• 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 crossfunctional and cross-site international teams

OTHER REQUIREMENTS:

• 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. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

• According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.​​

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.​

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.

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