---
title: 'Associate Director, Analytical Development and Quality Control at Kailera Therapeutics, Inc.'
canonical: 'https://feeny.ai/job/associate-director-analytical-development-and-quality-control-kailera-ykh2zdkjg74j'
type: 'job'
last_seen: '2026-09-05'
---

# Associate Director, Analytical Development and Quality Control at Kailera Therapeutics, Inc.

- **Company:** Kailera Therapeutics, Inc.
- **Location:** United States
- **Compensation:** $155k–$190k
- **Work type:** remote
- **Posted:** 2026-07-22
- **Last confirmed live:** 2026-09-05
- **Apply:** https://job-boards.greenhouse.io/kailera/jobs/5367443008

## 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 Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.

Responsibilities:

- Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances..
- Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance.
- Through our external network, lead the development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories.
- Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
- Author relevant CMC sections to enable global regulatory filings.
- Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed.
- Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making.
- Collaborate with cross-functional line functions to ensure CMC and program goals are met.
- Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.

Required Qualifications:

- A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.).
- Or an advanced degree with 5+ years
- Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation.
- Demonstrated analytical project leadership and cross-functional team participation.
- Experience in setting commercial specifications.
- Experience in authoring regulatory documents, including NDA experience
- Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements.
- Strong understanding of all applicable ICH guidelines.
- Method validation experience.
- Experience with oversight of the analytical activities at CDMOs and/or CTLs.
- Sound problem-solving skills with technically driven decision-making ability.
- Effective written and verbal communication and interpersonal skills.
- Innovative team-player with high energy for our dynamic company environment.

Preferred Qualifications:

- Knowledge and experience in analytical development of injectable products, and associated control strategies
- Knowledge and experience in analytical development of small molecules and solid oral dosage forms.
- Successful support of at least one NDA and commercial launch.
- Synthetic peptide manufacturing knowledge.
- Experience with statistics and applying statistics to analytical chemistry.
- Regulatory Inspection experience.

Education:

- A Bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience
- Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.

Additional Information:

- This position requires some travel to domestic and international destinations.
- In rare occasions, this position may require working in environments where there may be specific gowning or dress code requirements.

Salary Range $155,000—$190,000 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)

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