A company is looking for a CMC Digitalization Consultant to guide the team in digitizing the Chemistry, Manufacturing, and Controls (CMC) process.
Key Responsibilities
Analyze the end-to-end CMC lifecycle and identify critical workflows and pain points
Engage cross-functional teams to align requirements and document stakeholder responsibilities
Ensure compliance with global regulatory standards and develop a roadmap for submission-ready documentation
Required Qualifications
10+ years of experience in life sciences, focusing on CMC processes
Proven track record in biologics manufacturing and regulatory submissions
Experience implementing FDA KASA or similar frameworks
Familiarity with LIMS, QMS, PLM, or eCTD tools
Knowledge of AI/ML applications is preferred
