CMC Project Manager – Late-Stage Biologics

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our Biotechnology Client is seeking an experienced CMC Project Manager to provide execution leadership across drug product and device work streams supporting BLA readiness and late‑stage commercialization activities.

This engagement is aligned to regulatory filing milestones, including PPQ execution, device verification and validation, and design control phase completion.

This critical CMC Project Manager will step into established project plans and roadmaps (Smartsheet‑based) and drive cross‑functional coordination, vendor oversight, and milestone execution through BLA submission and related post‑PPQ activities.

This role will report into the Senior Director of CMC Project Management.

• Step into established Smartsheet project plans and maintain execution momentum
• Facilitate cross‑functional meetings across CMC, device engineering, quality, and external vendors
• Maintain risk registers and contingency plans
• Provide executive‑ready updates aligned to filing timelines
• Manage action items/accountable parties across internal and external stakeholders to maintain project schedule integrity
• Drug Product Work streams (Focus Area)
  • Coordinate documentation and close‑out preparation supporting BLA submission
  • Ensure alignment between manufacturing, validation documentation, and regulatory timelines
  • Update integrated project timelines through BLA
  • Coordinate PPQ documentation readiness package
  • Weekly progress reporting and risk tracking
  • BLA‑aligned CMC milestone tracking dashboard and PPQ readiness tracker
  • Cross‑functional action log with risk mitigation plans
  • Executive‑level status updates tied to validation timelines
• Device Development & Design Controls (Focus Area)
  • Documentation coordination across device engineering, quality, and regulatory
  • Integrated device validation readiness plan, design control phase exit tracker
  • Updates to Verification & validation milestone dashboard
  • Cross‑functional documentation coordination (design history file readiness)
  • BLA‑aligned device submission tracking

• Minimum of 6+ years of experience in CMC project management within biotechnology or pharmaceutical space
• Proficiency with Smartsheet
• Demonstrated experience supporting late‑stage biologics programs
• Strong background in drug product development and external CMO oversight
• Ability to coordinate across multiple external vendors and internal SMEs
• Comfortable operating in nimble, fast‑moving environments and wearing multiple hats
• Experience with device development processes preferred, including:
  • Design controls
  • Verification and validation
  • Combination product familiarity preferred

REMOTE.

Immediate start. Initial contract period through September of 2027 with potential to extend.