Associate Director, Analytical Development and Quality Control - Remote

Overview

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.

In Short

• Support analytical development and QC activities related to characterization of drug substances and drug products.
• Maintain current knowledge in analytical methods and control strategies.
• Support development of analytical methods for Kailera’s product pipeline.
• Provide input for developing and implementing analytical development strategies.
• Support authoring of relevant CMC sections for global regulatory filings.
• Participate on cross-functional CMC teams.
• Communicate CMC project status to key stakeholders.
• Collaborate with cross-functional line functions.
• Travel to CDMOs and other service providers as needed.
• This position requires some travel to domestic and international destinations.

Requirements

• 5+ years of experience in the pharmaceutical/biotech industry.
• Extractable/leachable and mass spectrometry experience required.
• Demonstrated project and cross-functional team participation.
• Knowledge of drug development activities with respect to cGMP and global regulatory requirements.
• Experience with oversight of analytical activities at CDMOs.
• Sound problem-solving skills.
• Effective written and verbal communication skills.
• Innovative team-player with high energy.

Benefits

• Comprehensive health benefits and tax-advantaged savings accounts.
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown.
• Monthly wellness stipend.
• Generous 401(k) match.
• Disability and life insurance.