Lead CMC expertise at Indegene as a Senior Manager. This role focuses on building CMC capabilities and managing a writing team in a hybrid or remote setting.
Indegene seeks a Senior Manager specializing in CMC Operations and Writing with a strong educational background in Chemistry or Pharmacy. You will oversee a growing team dedicated to CMC documentation while engaging with clients on strategic consulting. Ideal candidates possess extensive experience in CMC operations and regulatory compliance across development stages.
Key Responsibilities:
• Mentor and expand a global team of CMC experts
• Represent CMC in client meetings and regulatory discussions
• Provide insight for client proposals and project scopes
• Oversee quality assurance of CMC documentation
• Collaborate with multiple teams for unified project delivery
Requirements:
• Bachelor’s and Master’s degree in scientific discipline
• 16–18 years of CMC operations experience
• Proven leadership ...