VP, CMC & Device Development for Obesity Therapies

OpenKrill; United States; Hybrid; USD 300,000 - 450,000; Full time

Job summary

Kailera Therapeutics is seeking a VP, CMC Drug & Device Development to own strategy across drug substance, product, device, and combination products. The role partners with Regulatory, Quality, Clinical Development, and Commercial to ensure robust, scalable supply chains and regulatory readiness.

The leader will build a growing CMC organization, interact with FDA/global health authorities, and drive technology transfer to CDMOs while aligning with milestone timelines and launch readiness.

Qualifications

• 15+ years in CMC leadership in biotech/pharma.
• 7+ years in senior leadership with drug substance/product development.
• Experience with injectable combination products and devices.

Responsibilities

• Own CMC strategy for full portfolio and device platforms.
• Lead drug substance/product development and technology transfer.
• Drive CMC cost optimization and process improvements.
• Oversee regulatory submissions and interactions with authorities.
• Build and mentor CMC and device engineering teams.
• Ensure 21 CFR Part 4 and ISO compliance.

Skills

CMC leadership

Device development

Regulatory collaboration

Cross-functional leadership

Strategic planning

Tools

CDMO management

Job description

Kailera Therapeutics is seeking a VP, CMC Drug & Device Development to own strategy across drug substance, product, device, and combination products. The role partners with Regulatory, Quality, Clinical Development, and Commercial to ensure robust, scalable supply chains and regulatory readiness.

The leader will build a growing CMC organization, interact with FDA/global health authorities, and drive technology transfer to CDMOs while aligning with milestone timelines and launch readiness.