enveda - Sr. CMC Project Manager
Requirements
• B.S., M.S., or Ph.D. (M.S. or Ph.D. preferred) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar field; PMP certification is a plus • 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; late-stage development experience is a plus • 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 • A fast-paced, results- and team-oriented start-up mindset, with flexibility, adaptability, and the resourcefulness to do more with less, plus excellent organizational, interpersonal, and problem-solving skills • We hire for trajectory, not just credentials. If you meet most of the above and care deeply about this problem, we want to hear from you.
Responsibilities
• As a Senior CMC Project Manager at Enveda, you'll own portfolio-level planning and execution of CMC development for our small-molecule assets, from initial tox supplies through Phase 2 scale-up across drug substance and drug product. You'll partner with our internal CMC team and with CDMOs across China, the EU, and the US to keep timelines, budgets, and regulatory submissions on track. Success in your first year looks like durable plans, risk registers, and workflows that let the CMC team move faster with more confidence. This is a high impact opportunity where you'll influence our small-molecule clinical pipeline while collaborating with some of the brightest minds in the industry. • Let’s build the future of medicine - together. • Remote | Full-Time | $135,000 - $150,000 • 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
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