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Sr. CMC Project Manager

13 hours, 23 minutes ago
United States
Full-time
Senior
Project Manager
Project and Program Management
Domo
Apply Now
Enveda Biosciences

Enveda Biosciences

Enveda Biosciences | Plant Powered Drug Discovery Engineering new drugs from nature with knowledge graphs, metabolomics, and ML Learn more Over 95% of the natural world is a chemical mystery. The scant 5% that science has managed to identify is the sou...

Biotechnology
51-200
Founded 2019
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Description

  • Lead program- and portfolio-level CMC planning and execution for multiple small-molecule drug substance and drug product assets.
  • Develop and maintain CMC project plans, development strategies, timelines, deliverables, and risk registers.
  • Serve as the primary day-to-day contact for CDMOs across China, the EU, and the US.
  • Oversee CRO and CDMO planning, manufacturing campaigns, batch timelines, and documentation deliverables.
  • Chair cross-functional and external partner meetings; document decisions, minutes, and action items.
  • Communicate project status, risks, and mitigation plans to internal teams and external partners.
  • Manage CMC proposals, purchase orders, and change orders for assigned projects.
  • Maintain multi-year CMC budget forecasts and spend models, including commitments, accruals, and variance analysis.
  • Operate and improve controlled CMC document review workflows.
  • Identify opportunities to accelerate timelines, streamline execution, and anticipate resourcing needs.

Requirements

  • B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; M.S. or Ph.D. preferred.
  • 5+ years of CMC project management experience in biotech or pharma.
  • Hands-on experience with small-molecule drug substance and drug product development from IND-enabling through early clinical phases.
  • Knowledge of analytical method development, process chemistry, formulation, and regulatory documentation.
  • Experience managing CROs and CDMOs across multiple geographies, including issue escalation and deliverable quality oversight.
  • Ability to lead cross-functional initiatives and manage priorities, timelines, and budgets in a fast-paced, resource-constrained environment.
  • Experience designing structured document workflows, approval processes, and standards in GxP and submission-relevant environments.
  • Experience or strong interest in applying AI and automation to operational workflows with appropriate human oversight.
  • Proficiency with tools such as Smartsheet, Box, Domo, Slack, and Zoom; comfort owning custom applications and integrations.
  • PMP certification and late-stage development experience are preferred.

Benefits

  • Salary range of $135,000–$150,000.
  • Remote, full-time role.
  • Medical, dental, and vision insurance covered at 90% starting on day one.
  • 401(k) with company match.
  • Flexible PTO and a company-wide weeklong recharge break.
  • Adoption assistance.

Interested in this position?

Apply directly on the company website

Apply Now

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