- Company Name
- Sanofi
- Job Title
- Upstream process Head
- Job Description
-
**Job Title**
Upstream Process Head
**Role Summary**
Lead the Vitry upstream/downstream MSAT team to ensure robust, compliant, and efficient biopharmaceutical manufacturing. Oversee technical support for commercial processes, lifecycle management, scale‑up, technology transfer, process validation, and regulatory compliance. Act as the primary interface between the site and Global MSAT, contributing to the site’s strategic roadmap and fostering cross‑functional collaboration.
**Expectations**
- Deliver measurable improvements in yield, robustness, and economics for cell‑culture and purification processes.
- Maintain high standards of scientific rigor, documentation, and regulatory adherence.
- Mentor and develop a high‑performance MSAT team.
- Communicate effectively with site leadership, CMC, analytical, and manufacturing partners.
- Drive projects to completion within agreed timelines and budgets.
**Key Responsibilities**
- Provide technical leadership to scientists and engineers in upstream and downstream development and validation.
- Design and execute studies, interpret data, and support significant change decisions.
- Lead technology transfer and process validation for new products and scale‑up.
- Define process control strategies and manage MSAT labs and small‑scale models.
- Coordinate regulatory filings, inspections, and compliance activities.
- Interface with CMC development teams to implement platform approaches across the network.
- Prioritize resources, manage project commitments, and report progress to Site Leadership.
- Foster team cohesion, accountability, and continuous improvement.
**Required Skills**
- Expertise in mammalian cell culture, process development, scale‑up, and downstream purification.
- Strong analytical, problem‑solving, and data‑driven decision‑making capabilities.
- Excellent leadership, coaching, and team‑building skills.
- Proven communication with cross‑functional teams and senior stakeholders.
- Knowledge of GMP, US/EU regulatory requirements, and quality system principles.
- Experience with validation protocols, change control, and documentation.
- Ability to manage multiple projects and deadlines in a dynamic environment.
**Required Education & Certifications**
- Master’s degree (or PhD) in Biological/Biomedical Sciences, Chemical Engineering, or related field.
- Minimum 10 years of biopharmaceutical industry experience in process development, scale‑up, or process validation.
- Certifications in GMP compliance, quality assurance, or related disciplines are a plus.