MSAT Material Science Leader

POSITION OVERVIEWJOB DESCRIPTION:This position is responsible for leading material science topics and acting as the scientific SME for material science representing MSAT. Key Responsibilities may change over time in accordance with business needs.Lead the development of key quality attributes of most critical raw materials used in Sanofi’s commercial biologics portfolio. Partner with MSAT and CMC Development Upstream, Downstream and Analytical SMEs for the identification of key quality attributes.

Facilitate the use of key quality attributes of the critical raw materials for raw material control and investigations.

Drive through partnerships within MSAT the conceptualization, development and use of data analytics and digital tools for raw material analysis that includes but is not limited to statistical process control / control charts for CoA attributes, correlation between raw material attributes and process performance etc.

Take a lead in understanding, addressing and mitigating raw material-driven manufacturing deviations. Establish best practices to manage process performance variability owing to raw materials.

Scientific SME on the communications with raw material suppliers for new raw material introduction and custom raw material design during biologics lifecycle process development.

Maintain awareness on global pharmacopeia updates and their impact to Sanofi’s portfolio. Participate as the bioprocess SME to develop the scientific strategy for managing the impact of the pharmacopeia updates.

Strategically seek out partnerships with industry peers to collaborate on raw material issues of common interest.

Partner with CMC Development to develop best practices for raw material selection across CMC.

Be an active participant through external engagement to present Sanofi’s position and promote Sanofi’s interests.

Participate in supplier meetings, as required.

Consult QC RM in developing a risk-based periodic material assessment strategy to confirm compliance of the raw materials with the CoA and previously qualified state.

BASIC QUALIFICATIONSPh.D. in Material Science or Bioengineering with 7 years industry experience in CMC biologics development, biologics manufacturing setting or in developing raw materials (e.g., filters, resins, SUTs, cell culture media) used in biologics manufacturing. Ph.D. in Biochemical Engineering, Physical / Analytical Chemistry or Chemical Engineering may be considered.

Good transversal understanding in Upstream, Downstream and Analytical techniques with deep expertise in minimum of one of three areas.

Strong understanding of polymers and chemicals, their function in bioprocesses and how they interact with cells and proteins.

Prior experience leading global cross-functional project teams.

PREFERRED QUALIFICATIONSStrong written and oral communication skills.

Demonstrated experience with leading risk assessments or risk-based approaches for raw materials, CMC development or validation.

Influencing across various organization levels in other departments.

Ability to forge alliances with vendors and industry peers.

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.#GD-SG#LI-GZAt 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.