Associate Director, Analytical Development, Quality Control

🕒 Julho 29

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Kailera Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2024

🔥 Investimento no último ano

💰 $600.000.000 Series B - Kailera Therapeutics em 2025-10

A Kailera Therapeutics (Kailera) está desenvolvendo um portfólio amplo, avançado e diferenciado de terapias injetáveis e orais em estágio clínico para o tratamento da obesidade. O programa mais avançado da Kailera, o KAI-9531 (sendo desenvolvido na China como HRS9531), é um agonista dual dos receptores GLP-1/GIP injetável que demonstrou resultados positivos em ensaios clínicos para obesidade na China. A empresa também está avançando com um pipeline diversificado utilizando vários mecanismos e vias de administração. A missão da Kailera é desenvolver terapias de controle de peso de próxima geração que proporcionem às pessoas o poder de transformar suas vidas e elevar sua saúde geral. A empresa está sediada em Waltham, MA, e San Diego, CA. Para mais informações, visite www.kailera.com.

Descrição

• Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances. • Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance. • Through our external network, lead the development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories. • Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization. • Author relevant CMC sections to enable global regulatory filings. • Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed. • Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making. • Collaborate with cross-functional line functions to ensure CMC and program goals are met. • Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.

🎯 Requisitos

• A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.). • Or an advanced degree with 5+ years • Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation. • Demonstrated analytical project leadership and cross-functional team participation. • Experience in setting commercial specifications. • Experience in authoring regulatory documents, including NDA experience • Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements. • Strong understanding of all applicable ICH guidelines. • Method validation experience. • Experience with oversight of the analytical activities at CDMOs and/or CTLs. • Sound problem-solving skills with technically driven decision-making ability. • Effective written and verbal communication and interpersonal skills. • Innovative team-player with high energy for our dynamic company environment.

🏖️ Benefícios

• Comprehensive health coverage • Flexible time off • Paid holidays • Year-end shutdown • Monthly wellness stipend • Generous 401(k) match • Tuition reimbursement • Commuter benefits • Disability and life insurance • Annual bonus opportunities • Equity grants