CMC Expert Analytical Development focus Parenterals&Devices

The Position

At Roche, we foster a culture of personal expression and genuine connection, aiming to prevent and cure diseases while ensuring global access to healthcare. We are seeking a senior scientific expert to join our Analytical R&D department.

Responsibilities

• Provide expert scientific guidance and strategic input to project teams and leadership.
• Mentor staff on NDA authoring and lead due diligence processes.
• Resolve complex CMC issues through root cause analysis and cross-functional collaboration.
• Shape scientific strategies and roadmaps using extensive pharmaceutical R&D experience.
• Drive continuous improvement by identifying portfolio-wide risks and implementing innovative solutions.
• Lead strategic cross-functional projects to enhance operational effectiveness.
• Mentor and train scientific staff to foster a culture of growth and knowledge sharing.

Requirements

• Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, or a related field.
• Extensive experience in pharmaceutical R&D, specifically in analytical development for parenterals, combination products, and synthetic molecule modalities.
• Proven track record in NDA preparation and project transfer to commercial manufacturing.
• Strong strategic problem-solving, analytical, and communication skills.
• Ability to influence and collaborate effectively within diverse, cross-functional teams.
• Commitment to staying current with scientific advancements and a passion for mentoring others.