Senior CMC PM - Remote, Global CDMOs, High Impact

Enveda; United States; Remote; USD 135,000 - 150,000; Full time

Benefits offered by this job

Health coverage 90%

401(k) match

Flexible PTO

Recharge break

Adoption assistance

Job summary

Enveda, a clinical-stage AI-enabled biotech, seeks a Senior CMC Project Manager to own portfolio-level planning and execution of CMC development for small-molecule assets. You’ll partner with our CMC team and CDMOs across China, the EU, and the US to keep timelines, budgets, and regulatory submissions on track.

You’ll lead cross-functional planning, manage external CROs/CDMOs, and drive a rolling multi-year CMC budget while improving document workflows in a fast-paced startup environment.

Qualifications

• 5+ years of CMC project management experience in biotech or pharma.
• Experience with IND-enabling to early clinical phases for small-molecule DM/DP.
• Experience managing external CROs and CDMOs across geographies.
• Strong cross-functional leadership and budgeting abilities.
• Interest in applying AI/automation to workflows with safety and transparency.

Responsibilities

• Lead portfolio-level planning and execution of CMC development across assets.
• Develop and own detailed CMC project plans and risk registers.
• Serve as main contact for external CDMOs across regions.
• Organize cross-functional meetings with clear agendas and minutes.
• Communicate project status, risks, and mitigations clearly.
• Own CMC proposal, PO, and change order pipeline.
• Maintain rolling multi-year CMC budget forecast and spend model.
• Operate multi-stage CMC document review workflow.
• Identify opportunities to accelerate timelines and optimize resourcing.

Skills

CMC project management

Biotech/pharma

CDMO management

GxP knowledge

Regulatory documentation

AI in ops

Smartsheet experience

Cross-functional leadership

Education

Chemistry or related field degree

Tools

Smartsheet

Box

Domo

Slack

Zoom

Job description

Enveda, a clinical-stage AI-enabled biotech, seeks a Senior CMC Project Manager to own portfolio-level planning and execution of CMC development for small-molecule assets. You’ll partner with our CMC team and CDMOs across China, the EU, and the US to keep timelines, budgets, and regulatory submissions on track.

You’ll lead cross-functional planning, manage external CROs/CDMOs, and drive a rolling multi-year CMC budget while improving document workflows in a fast-paced startup environment.