Director, Analytical Development and Quality Control (Fully Remote)

Kailera Therapeutics, Inc.; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Kailera Therapeutics, Inc. in the United States seeks an experienced leader to head analytical development and QC strategies for sterile injectable products, ensuring CMC readiness for IND/NDA submissions and commercial launches.

You will oversee method development, validation, transfer, stability, and external lab execution, partnering cross-functionally with QC, QA, Regulatory Affairs, Manufacturing and CDMOs.

Qualifications

• 10+ years in pharma/biotech with analytical leadership.
• Expertise in HPLC/UPLC and LC-MS methods.
• Experience with IND/NDA regulatory readiness.
• Strong cross-functional collaboration and project execution.

Responsibilities

• Lead analytical development and QC strategies for sterile injectables.
• Oversee method development, validation, transfer and stability studies.
• Collaborate with QC, QA, Regulatory Affairs, Manufacturing and CDMOs.
• Mentor staff and drive timely project delivery.

Skills

HPLC/UPLC

LC-MS

cGMP/ICH

Leadership

Mentoring

Job description

• Lead analytical development and QC strategies for sterile injectable products across the product lifecycle.
• Ensure regulatory CMC readiness for IND/NDA submissions and commercial launch.

What You'll Do:

• Oversee method development, validation, transfer, stability, and external laboratory execution.
• Partner cross-functionally with QC, QA, Regulatory Affairs, Manufacturing, and CDMOs.

Who You Are:

• Bring 10+ years of pharma/biotech experience with expertise in HPLC/UPLC, LC-MS, and cGMP/ICH standards.
• Combine strong technical leadership with project management and staff mentoring skills.

Kailera Therapeutics, Inc.

Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.