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 performed by our external partners for cGMP manufacturing, quality release, and stability.
• Work directly with technical counterparts at vendor sites to implement product controls.
• Ensure the integrity of data generated by external partners.
• Provide critical support for regulatory filings and ensure compliance with global regulatory standards.
• Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs).
• Oversee analytical activities conducted by CDMOs to ensure quality standards.
• Perform detailed review and provide data integrity oversight of data generated at CDMOs.
• Ensure analytical methods and data meet regulatory requirements.
• Contribute to the preparation of data summaries and reports for regulatory submissions.
• Provide technical guidance and support to internal teams and external partners.

Requirements

• Proven experience with peptides and small molecules in both injectable and solid oral dosage forms.
• Extractable/Leachable and Mass Spectrometry Experience.
• Experience managing outsourced activities with CDMOs.
• Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods.
• Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development.
• Effective communication and interpersonal skills.
• Ability to work effectively in a fast-paced, collaborative environment.
• Ph.D. or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience.
• Minimum of 6 years of experience in analytical development and quality control within the pharmaceutical or biotech industry.

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.