Sr. CMC Project Manager (Fully Remote)

Enveda; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

Enveda is a clinical-stage, AI-enabled biotech company discovering medicines four times faster than the industry standard. The company recently raised $311M in Series E funding and has been recognized as one of America's Best Startup Employers and a Top 100 Most Loved Workplace.

The Lead position will own portfolio-level planning and execution of CMC development for small-molecule assets, partnering across China, EU, and US to keep timelines and budgets on track, while accelerating timelines in

Qualifications

• 5+ years of CMC project management experience in biotech or pharma with hands-on exposure.
• Experience managing external CROs and CDMOs across multiple geographies.
• Demonstrated ability to lead cross-functional initiatives and manage timelines and budgets.

Responsibilities

• Lead portfolio-level planning and execution of CMC development for small-molecule assets from tox supplies through Phase 2 scale-up.
• Develop and own detailed CMC project plans and risk registers.
• Serve as the primary point of contact for external CDMOs and oversee planning and execution timelines.
• Maintain rolling multi-year CMC budget forecast and historical spend model.

Job description

• Lead portfolio-level planning and execution of CMC development for small-molecule assets from tox supplies through Phase 2 scale-up.
• Partner with internal CMC team and CDMOs across China, EU, and US to keep timelines, budgets, and regulatory submissions on track.
• Identify opportunities to accelerate timelines and streamline execution in a dynamic startup environment.

What You'll Do:

• Develop and own detailed CMC project plans and risk registers.
• Serve as the primary point of contact for external CDMOs and oversee planning and execution timelines.
• Maintain rolling multi-year CMC budget forecast and historical spend model.

What We're Looking For:

• 5+ years of CMC project management experience in biotech or pharma with hands-on exposure.
• Experience managing external CROs and CDMOs across multiple geographies.
• Demonstrated ability to lead cross-functional initiatives and manage timelines and budgets.

Enveda

Enveda is a clinical-stage, AI-enabled biotech company discovering medicines four times faster than the industry standard. The company recently raised $311M in Series E funding and has been recognized as one of America's Best Startup Employers and a Top 100 Most Loved Workplace.