Remote CMC Program Lead - Small Molecules

Amino Collective; United States; A distancia; USD 135.000 - 150.000; Jornada completa

Descripción de la vacante

Enveda is seeking a Senior CMC Project Manager to own portfolio-level planning for CMC development of small-molecule assets. You’ll coordinate with internal teams and CDMOs across China, the EU and the US to keep timelines, budgets and regulatory submissions on track.

You’ll lead cross-functional initiatives, manage risk and drive streamlined workflows, with a startup mindset and strong attention to detail. This remote, full-time role offers substantial impact and growth opportunities.

Formación

• 5+ years of CMC project management in biotech/pharma.
• Experience with small-molecule drug development from IND-enabling through early clinical phases.
• Familiar with analytical method development, process chemistry, formulation, regulatory docs.
• Experience managing external CROs/CDMOs across geographies.
• Ability to lead cross-functional initiatives and manage timelines and budgets.

Responsabilidades

• Lead portfolio-level planning and execution of CMC development for multiple assets.
• Develop and own detailed CMC plans, budgets, and risk registers.
• Coordinate with CDMOs in China, EU, and US; oversee timelines and documentation.
• Chair cross-functional meetings; track actions and decisions.
• Communicate project status and risks across teams.

Conocimientos

CMC project management

Biotech/pharma

Cross-functional leadership

Budgeting

CDMO management

Regulatory submissions

AI in operations

Modern tooling

Educación

Bachelor's in Chemistry/Pharma

PMP certification

Herramientas

Smartsheet

Box

Domo

Slack

Zoom

Descripción del empleo

Enveda is seeking a Senior CMC Project Manager to own portfolio-level planning for CMC development of small-molecule assets. You’ll coordinate with internal teams and CDMOs across China, the EU and the US to keep timelines, budgets and regulatory submissions on track.

You’ll lead cross-functional initiatives, manage risk and drive streamlined workflows, with a startup mindset and strong attention to detail. This remote, full-time role offers substantial impact and growth opportunities.