Associate Director, CMC Operations

Ladders; United States; Remote; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Flexible time off

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability & life insurance

Bonus & equity grants

Year-end shutdown

Job summary

The Ladders is seeking an Associate Director, CMC Operations to lead planning and execution of CMC workstreams from development through regulatory submission. This role partners with Technical Operations, CDMOs, Regulatory, Finance, and senior leadership to keep programs on track and ensure timely submissions.

The ideal candidate brings 10+ years in pharmaceutical drug development with 5+ years in CMC project management, strong Smartsheet use, budgeting experience, and a track record of

Qualifications

• 10+ years in pharmaceutical drug development, with 5+ years in CMC PM or related role.
• Strong understanding of CMC development, technology transfer, and manufacturing with CDMOs.
• Proven ability to manage multiple projects simultaneously.
• Advanced proficiency in Smartsheet for project timelines and dashboards.
• Experience in project budgeting, forecasting, and expense tracking.
• Excellent communication and presentation skills, especially with senior leadership.
• Demonstrated creativity and problem-solving skills in ambiguous situations.
• Experience working in interdisciplinary and cross-cultural teams.

Responsibilities

• Lead planning and execution of CMC workstreams from development to regulatory submission
• Build and maintain integrated CMC project plans and timelines in Smartsheet
• Facilitate cross-functional Technical Operations Program Teams, driving decisions and tracking action items
• Coordinate activities with CDMO partners, ensuring deliverables meet contracted timelines
• Identify and mitigate project risks and dependencies, developing contingency plans as needed
• Coordinate CMC contributions to regulatory submissions, tracking timelines for authoring and approvals
• Communicate project status and key issues to management and project teams in a timely manner
• Support departmental budget planning and expense tracking in collaboration with Finance
• Drive continuous improvement of CMC project management tools and processes

Skills

CMC project management

Pharmaceutical development

CDMO collaboration

Budgeting & forecasting

Cross-functional leadership

Executive communication

Risk management

Multitasking

Problem solving

Cross-cultural teamwork

Tools

Smartsheet

Job description

For our client, we are seeking a Associate Director, CMC Operations to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will lead the planning and execution of critical CMC workstreams spanning development through regulatory submission. The position requires close partnership with Technical Operations, CDMO partners, Regulatory, Finance, and senior leadership to keep programs on track, manage risk, and support high-quality decision-making.

The ideal candidate will bring deep CMC development and manufacturing experience, along with the ability to coordinate multiple initiatives in a fast-paced biotech environment. Success in this role will mean delivering disciplined project execution, strong cross-functional alignment, and clear visibility into timelines, budgets, and submission readiness.

Location: Remote

Compensation: $155,000 – $190,000 annually

Responsibilities

• Lead planning and execution of CMC workstreams from development to regulatory submission
• Build and maintain integrated CMC project plans and timelines in Smartsheet
• Facilitate cross-functional Technical Operations Program Teams, driving decisions and tracking action items
• Coordinate activities with CDMO partners, ensuring deliverables meet contracted timelines
• Identify and mitigate project risks and dependencies, developing contingency plans as needed
• Coordinate CMC contributions to regulatory submissions, tracking timelines for authoring and approvals
• Communicate project status and key issues to management and project teams in a timely manner
• Support departmental budget planning and expense tracking in collaboration with Finance
• Drive continuous improvement of CMC project management tools and processes
  
  

Qualifications

• 10+ years in pharmaceutical drug development, with 5+ years in CMC project management or a related role
• Strong understanding of CMC development, technology transfer, and manufacturing with CDMOs
• Proven ability to manage multiple projects simultaneously
• Advanced proficiency in Smartsheet for project timelines and dashboards
• Experience in project budgeting, forecasting, and expense tracking
• Excellent communication and presentation skills, especially with senior leadership
• Demonstrated creativity and problem-solving skills in ambiguous situations
• Experience working in interdisciplinary and cross-cultural teams
  
  

Benefits

• Comprehensive health coverage
• Flexible time off and paid holidays
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities and equity grants
• Year-end shutdown for work-life balance
  
  

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.