Scientist I, Analytical Development and Quality Control

Responsibilities

• Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
• Analyze and trend release and stability data to identify variability, shifts, and emerging quality risks, and communicate findings to departmental leadership and project teams
• Review release and stability test results to ensure accuracy, completeness, and compliance with specifications, procedures, GMP requirements, and overall data integrity
• Execute and support registration stability programs, including protocol implementation, sample management, and data evaluation across timepoints
• Apply scientific understanding of degradation pathways to interpret analytical data for trending purposes, and support investigations (OOS, OOT, deviations) and CAPA analysis
• Maintain and ensure integrity of data within LIMS and stability databases, ensuring accurate data entry, traceability, and audit readiness
• Conduct data integrity reviews and assessments in alignment with ALCOA+ principles, identifying gaps and supporting remediation actions as needed
• Author and review analytical reports and regulatory documentation, including sections supporting stability, specifications, and method performance
• Design and execute analytical experiments to support method lifecycle activities, including development, qualification/validation, transfer, or troubleshooting
• Collaborate with cross-functional teams to communicate data insights, support investigations, and contribute to project milestones and regulatory submissions
• Experience with data analysis tools (e.g., Excel advanced functions, JMP, or statistical software) for trending and visualization
• Working knowledge of ICH guidelines and regulatory expectations for analytical methods and stability programs
• Evaluate temperature excursions for stability and release samples, assessing potential impact on product quality using scientific judgment, stability data, and relevant regulatory/technical guidance
• Required Qualifications:
• 8+ years of hands-on experience with analytical techniques (e.g., HPLC/UHPLC, LC-MS, GC, compendial tests) supporting release and/or stability testing
• Experience trending and interpreting stability and QC data, with a working understanding of degradation pathways and stability-indicating methods
• Proficiency with LIMS and laboratory data systems, along with a strong understanding of data integrity principles (ALCOA+) and regulatory expectations
• Strong technical writing and communication skills, including experience reviewing analytical data and contributing to reports or regulatory documentation
• Demonstrated collaboration and problem-solving skills, with the ability to manage multiple priorities in a fast-paced, quality-focused environment

Requirements

• Experience supporting regulatory submissions (e.g., IND, NDA, BLA) with analytical or stability sections
• Familiarity with stability program design and lifecycle management in a pharmaceutical or biotechnology setting
• Experience participating in or supporting regulatory inspections and audits
• Exposure to method development, qualification/validation, or transfer activities within Analytical Development or QC
• Advanced degree preferred
• Education:
• Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline within a GMP-regulated environment
• Salary Range
• $106,000 - $130,000 USD
• For Full Time Roles: This range represents the company's

Benefits

Additional Information

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.

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