Senior Manager, Program Management and Drug Substance Lead

Vor BioBoston, MA
$155,000 - $175,000Onsite

About The Position

We are seeking a Senior Manager, Program Management & Drug Substance Lead to support execution of drug substance development and manufacturing programs for biologics. This role combines program management with hands-on understanding of CHO-based manufacturing to ensure activities are well-coordinated, risks are proactively managed, and supply aligns with clinical and commercial needs. You will play a key role in advancing programs through late-stage development by working across internal teams and external partners to deliver reliable, scalable drug substance supply.

Requirements

  • Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred
  • 6–10+ years of experience in biologics drug substance development, manufacturing, or CMC program management
  • Experience with CHO cell-based manufacturing systems required
  • Working knowledge of upstream (cell culture) and downstream (purification) processes
  • Experience supporting tech transfer, scale-up, and manufacturing execution
  • Experience working with external manufacturing partners (CDMOs)
  • Strong program management and data management skills; experience with tools such as Smartsheet preferred
  • Strong ability to manage timelines, track deliverables, and drive execution in a fast-paced environment.
  • Working knowledge of biologics drug substance development, including CHO cell culture, upstream and downstream processes.
  • Ability to work effectively across teams and manage competing priorities.
  • Strong analytical mindset with the ability to identify risks and support practical solutions.
  • Clear and organized communicator, able to provide concise updates to stakeholders.

Responsibilities

  • Drive day-to-day program execution across drug substance activities.
  • Develop and maintain integrated timelines, track deliverables, risks, and dependencies, and ensure alignment across CMC, Quality, Regulatory, Clinical, and Supply Chain teams.
  • Support drug substance activities for biologics, including CHO cell line–based processes.
  • Contribute to process development, tech transfer, scale-up, and manufacturing readiness.
  • Partner with technical teams to ensure processes are robust, scalable, and aligned with program timelines.
  • Coordinate activities across CDMOs and external partners.
  • Track manufacturing progress, ensure deliverables meet expectations, and escalate risks or issues as needed.
  • Support preparation for manufacturing campaigns and monitor execution.
  • Partner with Supply Chain to align drug substance manufacturing with clinical and commercial demand.
  • Support planning activities, including production scheduling, inventory tracking, and risk mitigation for supply continuity.
  • Identify program and technical risks and support development of mitigation plans.
  • Work cross-functionally to resolve manufacturing, process, or supply issues in a timely manner.
  • Coordinate across Quality, Regulatory, Clinical, Commercial, and Finance teams to ensure alignment on priorities, timelines, and deliverables.
  • Support regulatory documentation and ensure consistency of CMC information.
  • Maintain program plans, trackers, and dashboards using tools such as Smartsheet.
  • Ensure timelines, risks, and decisions are accurately captured and communicated through clear updates and reporting.

Benefits

  • comprehensive health coverage
  • flexible paid time off
  • generous parental leave
  • competitive 401(k)
  • education assistance
  • wellness resources
  • financial security
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