Head of MSAT Recombinant DS Platform and Specialty Care Business Partner - Framingham, United States - Sanofi Group

Description

Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

By driving its own transformation, Global MSAT fulfills an important function by providing day-to-day Manufacturing Support, focusing on technical and process aspects, effective Life Cycle Management, process robustness enhancement, and yield improvement to optimize performance.

Join our global network and contribute to the launch of 3 to 5 new products annually across various modalities, enabling us to reach and serve more patients and communities.

Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi's best-in-class ambition.

This global role will be tasked with the rapid creation of a new global MSAT Recombinant Protein organization and associated change management for about 300 people located in 5 countries and focused on recombinant Drug Substance processes including related analytics of all M&S GBUs.

It includes oversight over industrial development and processes on mammalian and microbial Drug Substances, analytical activities, manufacturing support and new product introductions into the M&S industrial site network.

This global role will be giving high performant & best in class organization set up in terms of right first time, accelerated deliveries and talent managements, as well as strategic scientific and technological direction for drug substance processes on recombinant products.

In cooperation with the global head of Injectables representing the Drug product part of those recombinant products the organizations impact significantly financial performance of the group.

In addition to the leadership of the technology platform for recombinant Drug Substances this role will be the Industrial Development Business Partner for the M&S GBU Specialty Care serving all products from an E2E perspective and representing MSAT in respective executive leadership teams, Scientific Boards with R&D and further decision-making committees.

Company-paid relocation benefits are being offered for this position.


MAIN RESPONSIBILITIES:

• Define, drive and implement strategies on Drug Substance technologies & industrial development for driving profitability, growth and launch of Sanofi's biologic's portfolio across GBUs by giving scientific and technological direction namely leveraging cutting edge science and technology. Full scope covered is therapeutic modalities of biologics and vaccines produced in mammalian cell culture and microbial systems like yeast, bacteria and baculoviruses.
• Be the unique representative of M&S Specialty Care GBU Leadership team and the voice of the GBU in MSAT function.
• Drive Change and Transformation of the organization and pioneer new organizational models, challenge the status quo and empower teams to focus on delivering business value and drive innovation and leverage Science and Technology for performance of the manufacturing network.
• Lead talent development and ensure performance mindset shift for the techno platform.
• Global leadership for Process LCM, scale up & process validation of new products transferred from CMC-Dev or next generation commercial processes. Take full accountability of Technology Transfers, process validation and control strategies of manufacturing processes entering M&S from R&D in Sanofi's entire manufacturing network and ensuring the new product launches.
• Ensure scientific and technical leadership is provided for commercial products (internal and CMOs) to prevent process related deviations (lead continued process verification, provide multi-site process oversight and ensure efficient routine process monitoring is delivered), as well as for complex troubleshooting across the sites and scientific support required to support discussions in inspections.
• Develop and lead integrated teams of biotechnologists, biochemists, process engineers, and bioanalytical experts to develop innovative, competitive, cost-efficient, sustainable, environmentally friendly and efficient manufacturing processes delivering on Growth and Profitability of Sanofi's entire biologics business. Ensure securing such intellectual property on manufacturing processes by filing process and technology patents for Sanofi.
• Lead, manage and ensure further develop MSAT internal pilot plant capabilities and produce technical and GMP batches as part of industrial development programs.
• Foster an external network of strategic partnerships with high profile academic laboratories as well as with key innovative biotechnology partners. Use and further develop cutting edge technologies as Automation, High Throughput Experimentation, continues processing in collaboration with internal and external partners.
• Develop strategies in collaboration with Global Regulatory Affairs as well as the Business Unit Franchise Heads and Global Supply Chain to industrialize next generation manufacturing processes and positioning them effectively in the global markets taking into account regulatory requirements as well as industrial volume strategies.

ABOUT YOU

• 
  Experience :
• Broad and long-term experience in the biologics/ biochemistry/ pharmaceutical industry in R&D and/or industrial development, industrial operations and GMP considerations, global CMC projects. 15 to 20 years of experience in a pharmaceutical company.
• 
  Soft skills :
• Strategic thinking:
• Results orientation
• Relationship & Influence
• Commit to Patients and full product quality.
• Issue resolution and decision-making skills
• 
  Technical skills :
• High experience in exposure to change management and transversal collaboration
• Proven capabilities to lead a cross-functional team in a matrix organization; Experience in strategic CMC/development project lead roles; Global exposure and stakeholder management experience
• Strong scientific background in biological processes (mammalian and/or microbial) and products in development, scale up, technology transfer and operation
• Good understanding of Financials and business case building
• 
  Education :
• PhD/Master's degree in Life Sciences and/or Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy or related.

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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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.