Associate II, CMC Operations

Kailera Therapeutics•Waltham, MA

6d•Hybrid

About The Position

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. Reporting to the Associate Director, CMC Operations, the Associate II, CMC Operations will support the flawless execution of Kailera’s analytical CMC program management activities. The individual will collaborate with CMC core team representatives and bridge cross-functional CMC sub-teams to manage all analytical activities and timelines for Kailera’s multiple development projects.

Requirements

2-5 years of experience in pharmaceutical drug development and track record of success supporting multiple projects or programs simultaneously
Excellent communication skills
Proven track record of creativity, problem solving, and productivity
Demonstrated success working in interdisciplinary and cross-functional teams
Comfortable working in a dynamic, interactive, fast-paced, and entrepreneurial environment

Responsibilities

Participate in vendor meetings and track and manage analytical documents and deliverables
Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is occurring according to the contracted scope and schedule; work closely with analytical team to ensure invoices are submitted accurately
Assist with CMC analytical program budget by reviewing contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts
Support the Associate Director, CMC Operations by maintaining and updating appropriate CMC tracking tools, proactively communicating key issues and other critical topics, and escalating concerns in a timely manner
Assists in managing relationships and communication between Kailera and external partners or service providers as required