Description

You will lead CMC and life cycle management programs from development to commercial launch, partnering with cross-functional teams to create integrated timelines, manage budgets, and drive projects to completion.

Requirements

• B.S./B.E. in chemical engineering, bioengineering or related field; MS/PhD a plus
• 8+ years pharma/biotech industry experience in technical operations
• 5+ years project management experience; PM certificate a plus
• Strong understanding of CMC development, GMP, and regulatory filing timelines
• Ability to manage complex cross-functional projects and third-party relationships

Responsibilities

• Lead and facilitate CMC and LCM cross-functional teams
• Establish comprehensive, end-to-end CMC timelines aligned with program strategy
• Identify and manage critical path activities, risks, and mitigations
• Develop and manage program budgets, including purchase orders and SOWs
• Present project updates, issues, and recommendations to senior management