Senior CMC Project Manager
New
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EnvedaBiopharmaceutical development
Remote, United StatesFull-TimeSenior
Salary135,000 - 150,000 USD per year
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Job Details
- Experience
- 5+ years of CMC project management experience
- Required Skills
- Project Management
Requirements
- Hold a B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar field; an M.S. or Ph.D. is preferred.
- Bring 5+ years of CMC project management experience in biotech or pharma.
- Have hands-on exposure to small-molecule drug substance and drug product development from IND-enabling through early clinical phases.
- Have familiarity with analytical method development, process chemistry, formulation, and regulatory documentation in small-molecule drug development.
- Have experience managing external CROs and CDMOs across multiple geographies, including planning, communication, deliverable quality, issue escalation, and closure.
- Demonstrate the ability to lead cross-functional initiatives, set priorities, and manage timelines and budgets in a resource-constrained environment.
- Have experience designing and operating structured document workflows, approval processes, and standards in a GxP and submission-relevant context.
- Have experience or strong interest in applying AI and automation to operational workflows, with attention to safety, transparency, and human oversight.
- Be comfortable with Smartsheet, Box, Domo, Slack, and Zoom, and building or owning custom applications and integrations.
- Have strong oral and written communication skills, organizational skills, interpersonal skills, and problem-solving skills.
Responsibilities
- Lead program- and portfolio-level CMC development planning and execution for multiple small-molecule assets, from initial tox supplies through scale-up across drug substance and drug product.
- Develop and own detailed CMC project plans and risk registers, and track development strategies, timelines, and deliverables.
- Serve as the day-to-day primary contact for external CDMOs across China, the EU, and the US.
- Oversee CRO and CDMO planning, manufacturing campaign and batch execution timelines, and documentation deliverables.
- Organize and chair cross-functional and CDMO meetings, and track agendas, minutes, actions, and decisions.
- Communicate project status, risks, and mitigation strategies to internal teams and external partners.
- Manage the CMC proposal, purchase order, and change order pipeline for assigned projects.
- Maintain multi-year CMC budget forecasts and historical spend models, and oversee commitments, accruals, and variance analysis.
- Operate and improve controlled, multi-stage CMC document review workflows.
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