Associate Director, CMC Operations

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

Reporting to the Vice President, Technical Operations Portfolio Management, the Associate Director, CMC Operations will drive the planning and execution of Kailera’s programs, spanning technical development, CDMO partnerships, technology transfers, clinical and commercial manufacturing, and preparation of regulatory submissions. In partnership with Technical Operations core team representatives, the individual will support cross-functional Technical Operations Program Teams, build and maintain integrated CMC timelines, and manage risks, dependencies, and decisions across Kailera’s multiple development programs. The Associate Director will also support the preparation, forecasting, and monitoring of departmental budgets.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

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