Sr. CMC Project Manager

Enveda is hiring a Senior CMC Project Manager to lead portfolio-level planning and execution of CMC development for small-molecule assets, from initial toxicology supplies through Phase 2 scale-up. The role coordinates internal teams and external CROs and CDMOs, managing project plans, budgets, timelines, risks, and documentation.

Responsibilities:

• Lead program-level and portfolio-level planning and execution of CMC development 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 partner with internal and external teams to define and track development strategies, timelines, and deliverables, ensuring on-time, in-scope, and within-budget delivery
• Serve as the day-to-day primary point of contact for external CDMOs across China, the EU, and the US, and oversee CRO and CDMO planning, manufacturing campaign and batch execution timelines, and documentation deliverables
• Organize and chair recurring cross-functional and CDMO meetings with clear agendas, written minutes, and tracked action items, and support Project Leaders with agenda development, action tracking, and decision documentation
• Provide clear, concise communication of project status, risks, and mitigation strategies across internal teams and external partners
• Own the CMC proposal, purchase order, and change order pipeline for your assigned projects
• Maintain a rolling multi-year CMC budget forecast and historical spend model, overseeing commitments, accruals, and variance analysis down to PO line, program, activity stage, and budget item
• Operate and continuously improve a controlled, multi-stage CMC document review workflow
• Identify opportunities to accelerate timelines, streamline execution, and anticipate resourcing needs in a dynamic startup environment

Requirements:

• B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar field
• 5+ years of CMC project management experience in biotech or pharma, with hands-on exposure to small-molecule drug substance and drug product development from IND-enabling through early clinical phases
• Familiarity with small-molecule drug development, including analytical method development, process chemistry, formulation, and regulatory documentation
• Experience managing external CROs and CDMOs across multiple geographies, including planning, communication, quality of deliverables, and issue escalation and closure
• Demonstrated ability to lead cross-functional initiatives, set priorities, and manage timelines and budgets in a resource-constrained, fast-paced environment
• Proven ability to design and operate structured document workflows, approval processes, and standards in a GxP and submission-relevant context
• Experience or strong interest in applying AI and automation to operational workflows, with an emphasis on safety, transparency, and human oversight
• Strong technical and operational aptitude with modern tooling (Smartsheet, Box, Domo, Slack, Zoom) and comfort building or owning custom applications and integrations
• Excellent oral and written communication skills, with the ability to translate technical detail into clear project updates for diverse stakeholders
• excellent organizational, interpersonal, and problem-solving skills
• M.S. or Ph.D
• PMP certification is a plus
• late-stage development experience is a plus
• A fast-paced, results- and team-oriented start-up mindset, with flexibility, adaptability, and the resourcefulness to do more with less