Sr. CMC Project Manager

Let’s build the future of medicine - together.

YOUR ROLE

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.

WHAT YOU'LL DO

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

WHAT WE'RE LOOKING FOR

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