Associate Director, CMC Operations
Kailera Therapeutics
Posted: 10/19/2026PMP
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Posted: 10/19/2026Associate Director, CMC Operations
Kailera TherapeuticsPosted 10/19/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $155,000 - $190,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in CMC project management within pharmaceutical drug development, including proficiency in managing cross-functional teams and coordinating regulatory submissions. Capable of building integrated project plans and timelines while effectively communicating project status and managing risks.
Highest-signal resume keywords
CMC Project ManagementSmartsheet ProficiencyRegulatory Submissions ExperienceCross-Functional Team LeadershipPMP Certification
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Drive planning and execution of Kailera’s programs across technical development, CDMO partnerships, technology transfers, clinical and commercial manufacturing, and regulatory submissions
- Support cross-functional Technical Operations Program Teams
- Build and maintain integrated CMC timelines
- Manage risks, dependencies, and decisions across multiple development programs
- Lead CMC workstreams from technical development through regulatory submission and product approval
- Build integrated CMC project plans and timelines in Smartsheet, aligning drug substance, drug product, analytical, packaging, and supply activities with clinical and regulatory milestones
- Lead or facilitate cross-functional Technical Operations Program Teams, including agendas, decisions, action items, risks, and issues
- Coordinate CDMO activities, technology transfers, and manufacturing campaigns
- Identify and mitigate project risks and critical-path dependencies; develop contingency plans
- Coordinate CMC contributions to regulatory submissions
- Collaborate with Technical Operations, Quality, Regulatory, Clinical Supply, and Finance
- Communicate project status, key issues, and critical topics through dashboards and governance updates
- Ensure quality, scope, and timelines across assigned projects
- Support departmental budget planning, forecasting, and expense tracking
- Improve CMC project management tools, templates, and processes
Requirements
What you’ll need- 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 preferred
- Experience supporting late-stage development and marketing application submissions (e.g., NDA Module 3) preferred
- Bachelor's degree in a scientific discipline preferred; advanced degree a plus
- Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires
Benefits
Comp & perks- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability insurance
- Life insurance
- Annual bonus opportunities
- Equity grants
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical Drug DevelopmentTechnology TransferClinical ManufacturingCommercial ManufacturingIntegrated TimelinesProject BudgetingExpense TrackingRisk ManagementContingency PlanningDashboard Creation
Soft Skills
Excellent CommunicationFacilitation SkillsPresentation SkillsProblem SolvingCreativity
Tools & Technologies
Smartsheet
Certifications & Qualifications
PMP Certification
Industry Keywords
CDMO PartnershipsRegulatory ComplianceNDA Module 3Interdisciplinary TeamsCross-Cultural Teams