VP, CMC & Drug Delivery Innovation

Kailera Therapeutics, Inc.; United States; Hybrid; USD 272,000 - 340,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Wellness stipend

Equity grants

Annual bonus opportunities

Commuter benefits

Job summary

Kailera Therapeutics, Inc. is seeking a strategic leader for CMC Development and Drug Delivery Innovation. You’ll own CMC strategy across drug substance, product and device platforms, guiding late-stage programs toward regulatory filing and commercial readiness.

You will build and mentor a high-performing team, drive regulatory submissions, partner with Regulatory, Quality, and Commercial, and ensure a scalable, compliant supply chain while navigating the hub-based/remote working model.

Qualifications

• 15+ years of progressive CMC leadership in biotech/pharma.
• 7+ years in senior leadership with drug substance, product and device responsibility.
• Experience with injectable combination products and CDMO oversight.
• Authoring CMC sections for BLA/NDA/MAA and regulatory interactions with FDA.
• Proven ability to build and scale technical teams and supply chains.
• Willingness to relocate or travel; hub-based in Waltham, MA or remote with travel ~25%.
• Experience managing CDMO relationships and device suppliers.

Responsibilities

• Own CMC and device strategy across drug substance, product, and device platforms.
• Lead development, tech transfer, and scale-up for clinical and commercial manufacturing.
• Drive CMC operational excellence, cost optimization, and supply continuity.
• Oversee analytical method development and validation across substances and devices.
• Direct device development, DHF ownership, design controls, and risk management.
• Build and mentor a high-performing CMC and device engineering team.
• Partner with Regulatory, Quality, Clinical, and Commercial to align timelines.
• Manage budget, external spend, and vendor contracts.
• Ensure compliance with cGMP and global regulations across supply chains.

Skills

CMC leadership

Regulatory collaboration

Device development

Team leadership

Budget management

Strategic planning

Cross-functional collaboration

Quality & regulatory compliance

Lean, fast-moving execution

Executive communication

Education

Advanced degree in chemistry / pharmaceutical sciences / chemical engineering

Job description

Kailera Therapeutics, Inc. is seeking a strategic leader for CMC Development and Drug Delivery Innovation. You’ll own CMC strategy across drug substance, product and device platforms, guiding late-stage programs toward regulatory filing and commercial readiness.

You will build and mentor a high-performing team, drive regulatory submissions, partner with Regulatory, Quality, and Commercial, and ensure a scalable, compliant supply chain while navigating the hub-based/remote working model.