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Sanofi Group Principal Engineer, Upstream in Framingham, Massachusetts

Position: Principal Engineer, Upstream, MSAT

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.

Position overview:

The successful candidate will work with a group of scientists and engineers responsible for technology transfer mammalian cell culture processes to a diverse network of manufacturing facilities, Lifecycle Management and support of commercial processes. We are looking for a candidate with excellent scientific, communication, and project management skills. This individual will work in a fast-paced team environment, collaborating with colleagues across functions in the organization to solve a wide range of complex problems in creative and practical ways.

Responsibilities:

  • Lead technical support to Framingham site upstream commercial process operations (5+ commercial products).

  • Lead complex manufacturing technical investigations across global biologics manufacturing network.

  • Provide technical leadership in process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement

  • Utilize a solid understanding of scientific principles and professional practices to solve a range of complex deviations and technical issues in manufacturing in creative and practical ways.

  • Lead technology transfer, scale-up, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale.

  • Author and support regulatory filings and health authority inspections. Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.

  • Involve in design of new facilities

  • Interact with CMC process development teams on Cycle 2 and Cycle 3 process design and control strategy finalization in terms of facility/equipment specifics, manufacturability, capacity and cost analysis, process controllability and robustness.

  • Drives innovative solutions, evaluate and implement innovative technologies within organization and with external collaborations.

  • Build a network and maintain good relationship with both internal and external stakeholders

  • Work collaboratively with technical leads and SMEs in the downstream, analytical, and pilot lab areas.

  • Represent MSAT to interact with Manufacturing/quality/regulatory

  • Represent Upstream team as an SME or technical lead in cross-site, cross-functional teams

  • Provide input and coordinates support from Process development teams. Coordinates with cross functional teams to progress investigation and LCM related lab studies.

  • Attend development and scientific meetings to remain current with technology and regulatory guidelines. Interact with colleagues from various company functions in particular Engineering, Science, Manufacturing, Quality, and MSAT functions to meet the group’s goals.

  • Provide technical/scientific guidance and coaching to a group of engineers and help development of staff to maximize individual team performance.

Position: Principal Engineer, Upstream, MSAT

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.

Position overview:

The successful candidate will work with a group of scientists and engineers responsible for technology transfer mammalian cell culture processes to a diverse network of manufacturing facilities, Lifecycle Management and support of commercial processes. We are looking for a candidate with excellent scientific, communication, and project management skills. This individual will work in a fast-paced team environment, collaborating with colleagues across functions in the organization to solve a wide range of complex problems in creative and practical ways.

Responsibilities:

  • Lead technical support to Framingham site upstream commercial process operations (5+ commercial products).

  • Lead complex manufacturing technical investigations across global biologics manufacturing network.

  • Provide technical leadership in process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement

  • Utilize a solid understanding of scientific principles and professional practices to solve a range of complex deviations and technical issues in manufacturing in creative and practical ways.

  • Lead technology transfer, scale-up, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale.

  • Author and support regulatory filings and health authority inspections. Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.

  • Involve in design of new facilities

  • Interact with CMC process development teams on Cycle 2 and Cycle 3 process design and control strategy finalization in terms of facility/equipment specifics, manufacturability, capacity and cost analysis, process controllability and robustness.

  • Drives innovative solutions, evaluate and implement innovative technologies within organization and with external collaborations.

  • Build a network and maintain good relationship with both internal and external stakeholders

  • Work collaboratively with technical leads and SMEs in the downstream, analytical, and pilot lab areas.

  • Represent MSAT to interact with Manufacturing/quality/regulatory

  • Represent Upstream team as an SME or technical lead in cross-site, cross-functional teams

  • Provide input and coordinates support from Process development teams. Coordinates with cross functional teams to progress investigation and LCM related lab studies.

  • Attend development and scientific meetings to remain current with technology and regulatory guidelines. Interact with colleagues from various company functions in particular Engineering, Science, Manufacturing, Quality, and MSAT functions to meet the group’s goals.

  • Provide technical/scientific guidance and coaching to a group of engineers and help development of staff to maximize individual team performance.

BASIC REQUIREMENTS: (Must meet all the Required skills below to be considered)

  • BS degree with 12 years, or MS with 10 years, or PhD with 7 years of relevant experience;

  • Degree in life sciences, engineering, or other similar degree with minimum years of experience

  • Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations

  • Demonstrated ability to become a cell culture SME in a relevant field, e.g. PAT, process modelling and simulation, process intensification, bioreactor scale up / down, or process automation or miniaturization

  • Knowledgeable with other cell culture systems or modalities, such as insect cell culture or gene / cell therapy

  • Hands-on experience with mammalian cell culture process development at laboratory, pilot, or manufacturing scale

  • Knowledge in, bioreactor design and control strategies, scale up and scale down approaches as applied to mammalian-expressed proteins

  • Experience with high level data analysis.

COMPETENCIES / OTHER SKILLS:

  • Excellent scientific background, technical writing, and presentation skill

  • Highly motivated individual with the ability to work independently and on cross-functional and cross-site teams

  • Self-motivated with excellent attention to detail and superb organizational skills, having a proven ability to work in a highly collaborative environment and communicate transversally.

  • Flexible with ability to adjust to a fast-paced, goal-oriented environment and willingness to expand and broaden skillset.

  • Experience coaching and developing scientific staff

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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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.

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