Vice President, CMC Development and Drug Delivery Innovation

The role

The Vice President, CMC Drug & Device Development will own CMC strategy and execution across a portfolio of GLP-1-based therapies. This leader will manage drug substance, drug product, device, and oral solid dose formulation development to advance the pipeline toward commercial launch.

What you will do

• Own the CMC strategy for the full portfolio including injectable and oral formulations
• Lead drug substance and drug product development, scale-up, and technology transfer
• Drive CMC operational excellence and cost optimization
• Direct analytical method development, qualification, and validation
• Direct end to end device and combination product development
• Build and lead the human factors engineering strategy
• Ensure combination product compliance with global regulatory standards
• Author and oversee CMC and device sections of regulatory submissions
• Partner with the VP, External Manufacturing on CDMO strategy and selection
• Build, mentor, and lead a high-performing CMC and device engineering organization

Required qualifications

• 15+ years of progressive CMC leadership experience in biotechnology or pharmaceutical industry
• At least 7 years in senior leadership roles with direct accountability for drug substance, drug product, and device/combination product development
• Significant technical leadership experience with injectable combination products
• Working knowledge of ISO medical device standards, 21 CFR Part 4, and EU MDR Article 117
• Experience with oral solid dose formulation development
• Prior authorship and ownership of CMC sections for at least one BLA, NDA, or MAA submission
• Direct experience interacting with FDA and/or other health authorities on CMC and device matters
• Proven track record building, leading, and scaling technical teams
• Experience managing CDMO and device supplier relationships
• Advanced degree (Ph.D., or M.S./B.S. with equivalent industry experience) in chemistry, chemical engineering, pharmaceutical sciences, biomedical/mechanical engineering, or a related discipline

Nice to have

• Experience in obesity, metabolic, or cardiometabolic therapeutic areas, particularly with GLP-1 or peptide-based therapeutics
• Prior experience at a late clinical-stage biotechnology company transitioning toward commercial launch
• Experience scaling a CMC or Technical Operations function from a lean, pre-commercial organization
• Familiarity with global regulatory filings beyond the U.S.

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance

Before you apply

• Remote employees must adhere to the Hub & Home working model, including a minimum of one week per month in the Waltham, MA corporate office
• Kailera Therapeutics, Inc. uses E-Verify to confirm identity and employment eligibility

About the company

Kailera is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1-based therapies for people living with obesity. The company is rooted in an entrepreneurial spirit and a team-oriented culture.