Associate Director, Analytical Development and Quality Control

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: The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.   Responsibilities: 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.     Required Qualifications: 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 partic...