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Kailera Therapeutics · 7 hours ago

Associate Director, CMC Operations

Waltham, Massachusetts

Full-time

Hybrid

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

10+ years exp

Kailera is committed to developing therapies that empower individuals to transform their lives and enhance their health. The Associate Director, CMC Operations will manage CMC activities, including financial management, alliance management, and regulatory submissions, while collaborating with cross-functional teams to support multiple development projects.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Support execution of CMC-related projects, culminating in the successful preparation of regulatory submissions and product approvals

Actively support Tech Ops strategies and goals by participating in and/or leading cross-functional CMC sub-teams

Work closely and collaboratively with Tech Ops, Quality, Regulatory, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management activities

Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members

Ensure quality, quantity, and timelines in all assigned projects

Update team members on project target dates and priorities. Proactively contributes to budget forecasts and tracking expenses

Qualification

Pharmaceutical drug developmentClinical manufacturingRegulatory submissionsSmartsheet softwareInterdisciplinary teamworkCommunication skillsProblem solving

Required

10+ years of experience in pharmaceutical drug development, clinical and/or commercial manufacturing familiarity, and track record of success supporting multiple projects or programs simultaneously

Excellent communication/presentation skills and proficiency in Smartsheet software

Proven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place

Demonstrated successful experience with working in interdisciplinary and cross-cultural teams