Senior CMC Operations Leader—Programs & Submissions

OpenKrill; United States; Hybrid; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Paid holidays

Bonus opportunities

Equity grants

Wellness stipend

Commuter benefits

Job summary

Kailera Therapeutics, Inc. is seeking an Associate Director, CMC Operations to drive planning and execution of CMC programs, including tech transfer, manufacturing, and regulatory submissions.

This hub-based role offers onsite 3-4 days per week in Waltham, MA or a remote option with periodic hub visits, joining a cross-functional team to manage integrated CMC timelines and budgets. The role requires extensive pharma development experience, strong Smartsheet skills, and a proven ability to lead

Qualifications

• 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 CDMO experience.
• 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.
• Demonstrated creativity and productivity in cross-functional, interdisciplinary environments.

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 milestones.
• Lead and/or facilitate cross-functional Technical Operations Program Teams: set agendas, drive decisions, track actions, 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.
• Coordinate CMC contributions to regulatory submissions, tracking authoring, review, and approval timelines.
• Work with Quality, Regulatory, Clinical Supply, and Finance teams to maintain efficient product development and budget management practices.
• Proactively communicate project status and key issues to management and project teams via dashboards and governance updates.
• Ensure quality, scope, and timelines are met across all assigned projects and keep teams aligned on priorities.
• Support departmental budget planning, forecasting, and expense tracking with Finance.
• Drive continuous improvement of CMC PM tools, templates, and processes.

Skills

CMC PM

Cross-functional leadership

Communication

Problem solving

Education

Bachelor’s degree in science

Advanced degree

Tools

Smartsheet

Job description

Kailera Therapeutics, Inc. is seeking an Associate Director, CMC Operations to drive planning and execution of CMC programs, including tech transfer, manufacturing, and regulatory submissions.

This hub-based role offers onsite 3-4 days per week in Waltham, MA or a remote option with periodic hub visits, joining a cross-functional team to manage integrated CMC timelines and budgets. The role requires extensive pharma development experience, strong Smartsheet skills, and a proven ability to lead