Note: The job is a remote job and is open to candidates in USA. Kailera Therapeutics is hiring an Associate Director, CMC Operations to plan and execute CMC programs spanning technical development, CDMO partnerships, manufacturing, and regulatory submissions. The role supports cross-functional program teams, maintains integrated timelines, manages risks and decisions, and contributes to departmental budgeting.
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
- Drive continuous improvement of CMC project management tools, templates, and processes
Skills
- 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
- PMP or equivalent project management certification
- Experience supporting late-stage development and marketing application submissions (e.g., NDA Module 3)
- Bachelor's degree in a scientific discipline preferred
- Advanced degree a plus
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- A year-end shutdown
- A monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities
- Equity grants
- Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month)
Company Overview