Senior CMC Operations Lead – Remote/Hybrid

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

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics in Waltham, MA, is seeking an Associate Director, CMC Operations, to drive planning and execution across development programs, technology transfers, and regulatory submissions. Hybrid onsite and remote work options are available with hub-based collaboration.

The role requires 10+ years in pharma drug development, strong leadership, and advanced Smartsheet skills, with budget forecasting and cross-functional leadership experience across CDMOs and clinical/regulatory

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 experience managing work with CDMOs.
• 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.

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 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 efficient practices for product development and budget management.
• Proactively communicate project status and issues to management and project teams, including 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

Program management

Cross-functional collaboration

Communication

Facilitation

Leadership

Education

Bachelor's degree in a scientific discipline

Advanced degree

Tools

Smartsheet

PMP certification

Job description

Kailera Therapeutics in Waltham, MA, is seeking an Associate Director, CMC Operations, to drive planning and execution across development programs, technology transfers, and regulatory submissions. Hybrid onsite and remote work options are available with hub-based collaboration.

The role requires 10+ years in pharma drug development, strong leadership, and advanced Smartsheet skills, with budget forecasting and cross-functional leadership experience across CDMOs and clinical/regulatory