Senior CMC Expert - Parenterals & Device Analytics

F. Hoffmann-La Roche AG; Schweiz; Vor Ort; EUR 150.150 - 193.050; Vollzeit

Zusammenfassung

Roche offers an advanced scientific leadership role in Analytical R&D, emphasizing NDA guidance, due diligence, and strategic CMC input. You will mentor staff and shape scientific roadmaps while collaborating with cross-functional teams to tackle complex challenges.

The position focuses on analytical development of parenterals and combination products with devices, guiding risk analyses and implementing portfolio-wide improvements.

Qualifikationen

• Advanced degree in a relevant field with emphasis on pharmaceutical sciences
• Extensive experience with NDA preparation and transfer to manufacturing
• Proven ability to guide complex CMC issues and risk analyses
• Strong communication and collaboration across diverse teams

Aufgaben

• Provide expert scientific guidance to project teams and leadership
• Lead NDA preparation and due diligence efforts
• Drive resolution of CMC issues and root cause analyses
• Mentor and train scientific staff across global teams

Kenntnisse

NDA guidance

Analytical development

Cross-functional leadership

Mentoring

Strategic thinking

Ausbildung

Ph.D. preferred

Jobbeschreibung

Roche offers an advanced scientific leadership role in Analytical R&D, emphasizing NDA guidance, due diligence, and strategic CMC input. You will mentor staff and shape scientific roadmaps while collaborating with cross-functional teams to tackle complex challenges.

The position focuses on analytical development of parenterals and combination products with devices, guiding risk analyses and implementing portfolio-wide improvements.