VP, CMC & Drug-Delivery Innovation

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

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability & life insurance

Annual bonus

Equity grants

Job summary

Kailera Therapeutics is seeking a senior CMC and device leader in the United States. The role drives registration-ready strategy for injectable and device products, coordinating development, validation, and regulatory submissions.

The job combines strategic planning with hands-on execution in a fast-paced biotech setting. The candidate will lead cross-functional teams, manage CDMO partnerships, and shape supply continuity as Kailera scales toward commercialization.

Qualifications

• 15+ years in biotechnology/pharma with 7+ years in leadership.
• Experience with injectable combination products and DHF.
• Experience in FDA/EU regulatory submissions for CMC/device.
• Proven ability to build, scale, and lead technical teams across functions.
• Willingness to work hybrid with travel to hub locations (Waltham, MA).

Responsibilities

• Own the CMC strategy for Kailera's portfolio (injectables, devices, and oral formulations).
• Lead drug substance/product development, scale-up, and tech transfer to sites and CDMOs.
• Drive CMC operational excellence and cost optimization across the product lifecycle.
• Direct analytical method development, qualification, and validation.
• Oversee device and combination product development end-to-end and DHF ownership.
• Build and mentor a high-performing CMC and device engineering organization.
• Collaborate with Regulatory, QA, Clinical, and Commercial teams to align deliverables.

Skills

Leadership

Executive communication

Cross-functional collaboration

Regulatory knowledge

Problem solving

Education

PhD or MS/BS in relevant field

Tools

CDMO management systems

Job description

Kailera Therapeutics is seeking a senior CMC and device leader in the United States. The role drives registration-ready strategy for injectable and device products, coordinating development, validation, and regulatory submissions.

The job combines strategic planning with hands-on execution in a fast-paced biotech setting. The candidate will lead cross-functional teams, manage CDMO partnerships, and shape supply continuity as Kailera scales toward commercialization.