Associate Director, CMC Operations
US-Remote · Massachusetts · USD 155,000-190,000 · 5+ years experience · Posted Oct 19, 2026
At a glance
- Experience
- 5+ years experience
- Location
- US-Remote · Massachusetts
- Salary
- USD 155,000-190,000
About the role
- Kailera is seeking an Associate Director, CMC Operations to drive the planning and execution of programs spanning technical development, CDMO partnerships, and technology transfers.
- The role supports cross-functional Technical Operations Program Teams, builds integrated CMC timelines, and manages risks, dependencies, and decisions.
Responsibilities
- Lead planning and execution of CMC workstreams across multiple development programs, from technical development through regulatory submission and product approval
- Build and maintain integrated CMC project plans and timelines in Smartsheet, aligning drug substance, drug product, analytical, packaging, and supply activities with clinical and regulatory milestones
- Lead and/or facilitate cross-functional Technical Operations Program Teams: set agendas, drive decisions, track action items, risks, and issues to resolution
- Coordinate activities with CDMO partners, including technology transfers and manufacturing campaigns, tracking deliverables against contracted scope and timelines
- Identify, assess, and mitigate project risks and critical-path dependencies, and develop contingency plans where needed
- Coordinate CMC contributions to regulatory submissions, tracking authoring, review, and approval timelines
- Work closely with Technical Operations team, Quality, Regulatory, Clinical Supply, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management
- Proactively communicate project status, key issues, and other critical topics in a timely manner to the appropriate management level and relevant project team members, including through dashboards and governance updates
- Ensure quality, scope, and timelines are met across all assigned projects, and keep team members updated on target dates and priorities
- Support departmental budget planning, forecasting, and expense tracking in partnership with Finance
Requirements
- 10+ years of experience in pharmaceutical drug development, including 5+ years in CMC project management or a related program management role
- Working knowledge of CMC development, technology transfer, and clinical and/or commercial manufacturing, including experience managing work with CDMOs
- Track record of success managing multiple projects or programs simultaneously
- Advanced proficiency in Smartsheet, with experience building integrated timelines and dashboards
- Experience with project budgets, forecasting, and expense tracking
- Excellent communication, facilitation, and presentation skills, including with senior leadership
- Proven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place
- Demonstrated successful experience working in interdisciplinary and cross-cultural teams
Preferred qualifications
- PMP or equivalent project management certification
- Experience supporting late-stage development and marketing application submissions (e.g., NDA Module 3)
- Advanced degree
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities and equity grants
Workplace
- Hub-based in Waltham, MA requiring onsite 3-4 days per week OR remote home-based requiring onsite at a hub 1 week every other month
Skills
- Smartsheet
