VP, CMC & Drug Delivery Innovation (Remote)

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 272,000 - 340,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Wellness stipend

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus

Job summary

Kailera Therapeutics, Inc. in Waltham, MA seeks a strategic VP of CMC Development and Drug Delivery Innovation to lead end-to-end CMC strategy for a GLP-1 portfolio.

You will own device and combination product development, scale-up, and regulatory submissions, partnering across Regulatory, Quality, Clinical, and Commercial to ensure robust supply chains. The role requires hands-on leadership, deep CMC expertise, and the ability to drive cost optimization, vendor relationships, and

Qualifications

• 15+ years in CMC leadership in biotechnology/pharmaceuticals.
• 7+ years in senior leadership with drug substance, drug product and device development.
• Experience with injectable combination products and design controls (DHF, risk mgmt).
• Authored CMC sections for BLA/NDA/MAA and regulatory interactions.

Responsibilities

• Own the CMC strategy for Kailera's full portfolio (drug product, device, and combination products).
• Lead drug substance/product development, scale-up, and tech transfer to clinical and commercial sites.
• Drive CMC operational excellence, cost optimization, and supply chain resilience.
• Direct device development end to end, including platform evaluation and design transfer to manufacturing.
• Build and lead human factors engineering for combination products for regulatory submissions.
• Ensure compliance with cGMP, ISO standards, and regulatory requirements across the supply chain.
• Author and oversee CMC and device sections of regulatory submissions and liaise with FDA/health authorities.
• Partner with External Manufacturing to align CDMO strategy and capacity with clinical and commercial needs.
• Grow a high-performing CMC and device engineering organization, with cross-functional alignment.
• Own risk management and supply continuity, including sourcing and contingency planning.
• Manage budget and external spend in partnership with Finance and Procurement.

Skills

CMC leadership

Executive communication

Cross-functional leadership

Device development

Design controls

CDMO management

Strategic planning

Regulatory interactions

Team building

Education

Ph.D. or MS/BS in chemistry or related field

Job description

Kailera Therapeutics, Inc. in Waltham, MA seeks a strategic VP of CMC Development and Drug Delivery Innovation to lead end-to-end CMC strategy for a GLP-1 portfolio.

You will own device and combination product development, scale-up, and regulatory submissions, partnering across Regulatory, Quality, Clinical, and Commercial to ensure robust supply chains. The role requires hands-on leadership, deep CMC expertise, and the ability to drive cost optimization, vendor relationships, and