SC-MSAT Product Leads chair, attend and/or present at various strategy, governance, or technical forums and meetings as representatives of SC-MSAT. The primary responsibility for SC-MSAT Product Leads is to lead the operational aspects of the Technical Product Team (TPT) meetings to drive DS, DP, and Analytical technical and strategic agendas and provide technical/strategic direction to TPT team members while being supported by Project Managers who facilitate the TPT meetings. Effective leadership of TPTs ensures product compliance, operational risk identification and mitigation, continued commercial supply, and alignment to regulatory submission plans during the lifecycle of the product. In collaboration with the SC-MSAT Business Partners, oversees the execution of product roadmaps and operational plans, including prioritization of critical projects aligned with product drivers, long-term capacity and supply planning, long-term regulatory strategies, product lifecycle decisions, etc. SC-MSAT Product Leads are responsible for one major or several products depending on product complexity. SC-MSAT Product Leads will primarily focus on traditional biologic product technologies.
Education & Experience:
- BS, MS, or Ph.D. in Biochemistry, Chemistry, Cellular and Molecular Biology, Chemical Engineering, or related scientific discipline
- 10+ years of experience in bioprocess development or biotechnology manufacturing or analytics
- Experience in technical transfer of biotechnology processes and biomanufacturing into regulated facilities for commercial production
- Excellent and effective verbal and written communication skills and ability to influence at all levels across IA Specialty Care and Contract Manufacturing Organizations (CMOs)
- Experience leading multi-disciplinary, matrixed teams; solid problem solver, and ability to think and work creatively to meet deadlines
- Extensive experience and in-depth scientific/technical knowledge of biotech products whether in process development, product development, scale-up, operations, or analytical (for example, mammalian cell culture, purification, analytical characterization, and process validation)
- End-to-end product understanding from drug substance to drug product fill/finish operations
- Compliance and/or regulatory experience with knowledge and understanding of various Boards of Health stances, requirements, and regulations
- Experience with pre- and post-launch activities (technology transfer, process validation, comparability design, continuous process verification, health authority regulations and inspection readiness, quality systems, regulatory guidances, etc.)
- Solid management, communication and interpersonal skills; ability to set, manage and influence individual and team goals
SC-MSAT Product Leads report to SC-MSAT Business Partners who manage specific product portfolios/clusters and partner with various internal and external sites and industrial product team(s) to drive the technical aspects/agendas of product lifecycle management and site support. SC-MSAT Product Leads report into the SC-MSAT Program Leadership organization which transversally supports the Drug Substance, Drug Product, and Analytical functions within the SC-MSAT organization.
- Immediately a permanent contract at Sanofi
- Full-time position in day shift (flexible working hour system)
- An attractive salary package with meal vouchers (worth €8), a DKV hospitalization insurance,..
- Career opportunities in a growing organization where involvement, integrity, entrepreneurial spirit and collaboration are driving values