Remote Senior CMC Program Lead (Biotech)

dimensioncap.com; United States; Remote; USD 135,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Flexible PTO

Company-wide recharge break

Adoption assistance

Job summary

Enveda is a clinical-stage, AI-enabled biotech company seeking a Senior CMC Project Manager to own portfolio-level CMC development plans across drug substance and drug product. You will coordinate internal teams and external CDMOs to align timelines, budgets and regulatory submissions, driving fast, compliant execution in a startup environment.

This remote, full-time role emphasizes strategic planning, risk management, and structured workflows to accelerate the development pipeline for

Qualifications

• BS, MS, or Ph.D. (MS 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

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

Skills

Cross-functional leadership

Project management

Communication

Problem solving

Agile / structured workflows

AI and automation interest

Education

BS/MS/PhD in Chemistry, Chemical Engineering, or Pharmaceutical Sciences (MS/PhD preferred)

Tools

Smartsheet

Box

Domo

Slack

Zoom

Job description

Enveda is a clinical-stage, AI-enabled biotech company seeking a Senior CMC Project Manager to own portfolio-level CMC development plans across drug substance and drug product. You will coordinate internal teams and external CDMOs to align timelines, budgets and regulatory submissions, driving fast, compliant execution in a startup environment.

This remote, full-time role emphasizes strategic planning, risk management, and structured workflows to accelerate the development pipeline for