Materials Science Leader

DEPARTMENT DESCRIPTION:

The Drug Substance Bioprocess Engineering & Innovation group is an integral part of Drug Substance function within Specialty Care Manufacturing Science and Analytical Technology (SC-MSAT) department within the Recombinant Mammalian DS Platform. 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 implementing 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 SC-MSAT department supports 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 SCMSAT has state of art laboratories and pilot facilities in the USA, Belgium, and France. The Bioprocess Engineering & Innovation group, within Drug Substance function, is comprised of technical experts who lead multiple 2nd generation process development programs based on innovative platforms to have transformational impact on industrial performance of our manufacturing sites.  This position is a Materials Science leader function within this team, and will be responsible for leading material science topics and acting as the scientific SME for material science representing MSAT.

This position’s 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 Biologics Development (BioDev) Upstream, Downstream and Analytical SMEs for the identification of key quality attributes.

• Drive mitigations for raw material-driven manufacturing deviations. Establish best practices to manage process performance variability.

• Lead MSAT in understanding correlations between raw material attributes and process performance through the use of data analytics, statistical process control, etc.

• 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.

• Guide BioDev on best practices for raw material selection during process development.

• 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.

MINIMUM BASIC QUALIFICATIONS:

• BS in related discipline with at least 6 years of industrial experiences in relevant fields.

• MS in related discipline with at least 4 years of industrial experiences in relevant fields.

• Ph.D. in related discipline with limited to no industrial experiences in relevant fields.

PREFERRED QUALIFICATIONS:

• Degree 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.

• Influencing across various global cross-functional project teams.

• Strong 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.

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