Scientist I, 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 Scientist I, Analytical Development and Quality Control is an experienced scientist within the Analytical Development and Quality Control (AD/QC) organization, with a primary focus on analytical quality control, method validations, stability programs, and data integrity. This role applies broad knowledge of analytical principles and QC practices to support release and stability testing, data trending, and lifecycle management of analytical methods.

The Scientist I is responsible for analyzing and interpreting stability and release data, identifying trends and potential quality risks, and applying a foundational understanding of degradation pathways to ensure product quality over time. This individual contributes to the maintenance and integrity of analytical data systems, including LIMS and stability databases, and ensures compliance with regulatory expectations and internal quality standards.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

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

Preferred Qualifications:

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 g…