--- title: 'Scientist I, Analytical Development and Quality Control at Kailera Therapeutics, Inc.' canonical: 'https://feeny.ai/job/scientist-i-analytical-development-and-quality-control-kailera-therapeutics-inc-06desqgtmash' type: 'job' last_seen: '2026-09-12' --- # Scientist I, Analytical Development and Quality Control at Kailera Therapeutics, Inc. - **Company:** Kailera Therapeutics, Inc. - **Location:** Waltham, MA - **Compensation:** $106k–$130k - **Posted:** 2026-06-22 - **Last confirmed live:** 2026-09-12 - **Apply:** https://job-boards.greenhouse.io/kailera/jobs/5270441008 ## Job description 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 good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us. ## EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances. E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. #LI-Hybrid ## About Kailera Therapeutics, Inc. ## Company Overview - **One-liner**: Kailera Therapeutics is an advanced clinical-stage biotechnology company developing a diversified pipeline of GLP-1‑based therapies for obesity and overweight. - **Entity Type**: Private (clinical stage; in‑licensed through a strategic collaboration with Jiangsu Hengrui Pharmaceuticals) - **Headquarters**: Waltham, Massachusetts, United States - **Founded**: Not publicly available - **Founders**: Not publicly available ## Core Business - **Primary industries**: Biotechnology / Obesity therapeutics - **Target customers**: B2B (pharma partnerships) and ultimately patients and healthcare providers managing obesity and overweight - **Mission**: To give people the power to restore their health and transform their lives by delivering category‑leading obesity management medications. [kailera.com/about-us](https://www.kailera.com/about-us/) ## Products & Services Kailera’s pipeline is designed to address diverse unmet needs in obesity care, building on clinical data from Hengrui’s trials in China. All candidates are in‑licensed from Hengrui with exclusive rights outside China, Hong Kong, Macau and Taiwan. - **Ribupatide (KAI‑9531)** – Once‑weekly injectable GLP‑1/GIP receptor dual agonist peptide; currently in a global Phase 3 program. - **Ribupatide oral tablet** – Once‑daily oral formulation of the dual agonist. - **KAI‑7535** – Oral small‑molecule GLP‑1 receptor agonist (clinical stage). - **KAI‑4729** – Once‑weekly injectable GLP‑1/GIP/glucagon receptor tri‑agonist (clinical stage). ## Market Standing - **Valuation / Market Cap**: Not disclosed (private company) - **Key Metric**: Total funding – not publicly available; revenue – none (pre‑commercial). Pipeline lead in Phase 3. - **Notable Investors / Partners**: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (strategic collaboration and in‑licensing partner). Leadership team includes veterans from Cerevel Therapeutics, Translate Bio, Bain Capital Life Sciences, Amgen, Frazier Life Sciences, and AbbVie. [kailera.com/leadership](https://www.kailera.com/leadership/) - **Growth Signals**: - Ribupatide clinical data presented at the American Diabetes Association (ADA) 2026. - Global Phase 3 program underway for ribupatide. - Multiple clinical‑stage candidates (oral, small molecule, tri‑agonist) targeting different patient needs. - Active hiring with 29 open positions (as of mid‑2026) across R&D, clinical, supply chain, regulatory, and corporate functions. [job-boards.greenhouse.io/kailera](http://job-boards.greenhouse.io/kailera) ## Competitive Advantages - **Diversified modality pipeline**: Injectable dual agonist, oral formulation, oral small molecule, and tri‑agonist – covering a broad range of patient preferences and treatment stages. - **Cross‑border development acceleration**: Access to Hengrui’s clinical data from China informs and de‑risks global trials. - **World‑class leadership**: CEO Ron Renaud (former CEO of Cerevel and Translate Bio, both acquired by AbbVie and Sanofi respectively). CMO Scott Wasserman, M.D. (former CEO of Latigo Biotherapeutics, former Amgen VP leading metabolic and cardiovascular portfolios). Commercial and operational executives from top pharma. [kailera.com/leadership](https://www.kailera.com/leadership/) - **Obesity‑first focus**: Pipeline deliberately built for the chronic, progressive nature of obesity, aiming to address the gap for greater weight loss and higher‑BMI patients. ## Strategic Focus Kailera’s immediate priority is advancing ribupatide through Phase 3 to regulatory submission while progressing the earlier‑stage oral and tri‑agonist programs. The company aims to “elevate the next era of obesity care” by delivering multiple options for patients no matter where they are in their treatment journey. [kailera.com/](https://www.kailera.com/) ## Why Work Here - **Culture (“Kai Values”)**: Emphasizes courage, collaboration, compassion, and commitment. The team operates with entrepreneurial spirit, transparency, and a patient‑centered mission. [kailera.com/join-our-team](https://www.kailera.com/join-our-team/) - **Work Model**: Hybrid and remote options available – many roles are based in Waltham, MA, but some (e.g., Statistical Programming, Clinical Quality Assurance) are listed as US‑Remote. - **Notable Perks**: Purpose‑driven work in a fast‑growing therapeutic area; opportunity to work with top industry veterans; exposure to a pipeline that spans multiple cutting‑edge modalities (injectable, oral, small molecule). - **Growth Opportunity**: With 29 open positions across all levels (Associate Director to Senior Director), the company is scaling rapidly, offering significant career advancement in a high‑impact field. ## Sources 1. [kailera.com](https://www.kailera.com/) 2. [kailera.com/about-us](https://www.kailera.com/about-us/) 3. [kailera.com/leadership](https://www.kailera.com/leadership/) 4. [kailera.com/join-our-team](https://www.kailera.com/join-our-team/) 5. [job-boards.greenhouse.io/kailera](http://job-boards.greenhouse.io/kailera) ## Other roles at Kailera Therapeutics, Inc. - [Senior Medical Director, Clinical Development](https://feeny.ai/job/senior-medical-director-clinical-development-kailera-therapeutics-inc-waltham-gn0s7z1c6sp7) — Waltham, MA - [Director, Financial Planning & Analysis (FP&A) - Technical Operations](https://feeny.ai/job/director-financial-planning-analysis-fp-a-technical-operations-kailera-vgv6b1ptrbyc) — Waltham, MA - [Senior Director, Clinical Data Management](https://feeny.ai/job/senior-director-clinical-data-management-kailera-therapeutics-inc-united-states-2bt1pfpx7jpf) — United States - [Manager, Accounting](https://feeny.ai/job/manager-accounting-kailera-therapeutics-inc-waltham-5ybgjacrvp21) — Waltham, MA - [Medical Director, Clinical Development](https://feeny.ai/job/medical-director-clinical-development-kailera-therapeutics-inc-united-states-c4kp9yagj1rx) — United States - [Associate II, CMC Operations](https://feeny.ai/job/associate-ii-cmc-operations-kailera-therapeutics-inc-waltham-6gt8fat5hjsf) — Waltham, MA - [Clinical Trial Manager](https://feeny.ai/job/clinical-trial-manager-kailera-therapeutics-inc-waltham-zpfgsqjszahx) — Waltham, MA - [Associate Director, Device Engineering](https://feeny.ai/job/associate-director-device-engineering-kailera-therapeutics-inc-united-states-fya6qbe6aepe) — United States - [Associate Director, Global Regulatory Labeling and Ad Promo](https://feeny.ai/job/associate-director-global-regulatory-labeling-and-ad-promo-kailera-therapeutics-x8ypw7d87een) — Waltham, MA - [Associate Director, Global Regulatory Affairs](https://feeny.ai/job/associate-director-global-regulatory-affairs-kailera-therapeutics-inc-waltham-zfq2ybe43kx0) — Waltham, MA