Senior CMC Expert - Parenterals & Device Analytics

F. Hoffmann-La Roche AG; Schweiz; On-site; EUR 150,150 - 193,050; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

NDA guidance

Analytical development

Cross-functional leadership

Mentoring

Strategic thinking

Education

Ph.D. preferred

Job description

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.