Associate Director, CMC Operations & Program Delivery

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Equity grants

Job summary

Kailera Therapeutics, Inc. in the United States seeks an experienced Associate Director, CMC Operations to drive planning and execution across CMC workstreams, from development through regulatory submission.

The role partners with CDMOs, technology transfers, and manufacturing, building integrated timelines and budgets in a fast-paced, hub-based environment. The position requires strong leadership, cross-functional collaboration, and a track record of delivering complex programs on time.

Qualifications

• 10+ years in pharmaceutical drug development with 5+ years in CMC project management
• Experience with CDMOs and technology transfers
• Track record of managing multiple projects simultaneously
• Advanced proficiency in Smartsheet with integrated timelines
• Experience with budgets, forecasting and expense tracking
• Excellent communication and leadership, including with senior leadership
• Experience working in cross-cultural, interdisciplinary teams

Responsibilities

• Lead planning and execution of CMC workstreams from development through submission
• Build integrated CMC project plans and timelines in Smartsheet
• Lead cross-functional Technical Operations Program Teams; set agendas and track items
• Coordinate activities with CDMO partners including tech transfers and manufacturing campaigns
• Identify and mitigate risks and dependencies; develop contingency plans
• Coordinate CMC contributions to regulatory submissions and timelines
• Work with Technical Operations, Quality, Regulatory, Clinical Supply, Finance to maintain efficient practices
• Communicate project status to management and teams via dashboards
• Ensure quality, scope, and timelines; keep team updated on dates
• Support departmental budget planning, forecasting and expense tracking with Finance
• Drive continuous improvement of CMC PM tools and processes

Skills

CMC project management

Smartsheet proficiency

Budgeting & forecasting

Communication & presentation

Cross-functional leadership

Risk management

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

Smartsheet

Job description

Kailera Therapeutics, Inc. in the United States seeks an experienced Associate Director, CMC Operations to drive planning and execution across CMC workstreams, from development through regulatory submission.

The role partners with CDMOs, technology transfers, and manufacturing, building integrated timelines and budgets in a fast-paced, hub-based environment. The position requires strong leadership, cross-functional collaboration, and a track record of delivering complex programs on time.