Principal Analytical Scientist - 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

• The Principal Analytical Scientist will support analytical development and quality control activities.
• Work with external partners for cGMP manufacturing and quality release.
• Implement product controls and ensure data integrity.
• Support regulatory filings and compliance with global standards.
• Oversee analytical activities conducted by CDMOs.
• Perform data integrity oversight and method validation.
• Contribute to data summaries and regulatory submissions.
• Ensure compliance with GMP and ICH guidelines.
• Provide technical guidance to internal teams and partners.
• Prepare and review technical documents.

Requirements

• Experience with peptides and small molecules.
• Experience managing outsourced activities with CDMOs.
• Expertise in analytical techniques such as HPLC, UPLC, MS, GC.
• Knowledge of FDA, EMA regulations and ICH guidelines.
• Effective communication and interpersonal skills.
• Ability to work in a fast-paced environment.

Benefits

• Comprehensive health benefits and savings accounts.
• Flexible time off and paid holidays.
• Monthly wellness stipend.
• Generous 401(k) match.
• Disability and life insurance.