Vice President, CMC Development, Drug Delivery Innovation

Kailera Therapeutics

. Own CMC strategy for Kailera’s portfolio of injectable, device/combination, and oral solid dose products .

Posted 10/16/2026full-timeWaltham • Massachusetts • United StatesLead💰 $272,000 - $340,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in CMC strategy, drug substance and product development, and regulatory compliance within the biotechnology and pharmaceutical sectors. Proven ability to lead cross-functional teams, manage complex projects, and ensure adherence to quality standards and regulatory requirements.

Highest-signal resume keywords

CMC Strategy OwnershipDrug Substance DevelopmentRegulatory Submission AuthorshipTechnical Leadership in Combination ProductsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process CharacterizationAnalytical Method DevelopmentRisk ManagementDesign ControlsScale-UpTechnology TransferOral Solid Dose Formulation DevelopmentDevice/Combination Product DevelopmentQuality System ComplianceCDMO Management

Soft Skills

Executive CommunicationTeam BuildingMentoringCollaboration

Certifications & Qualifications

Ph.D.M.S.B.S.

Industry Keywords

CGMPISO 13485ISO 14971FDA InteractionBLANDAMAAEU MDRBiotechnologyPharmaceutical

About the role

Key responsibilities & impact

Own CMC strategy for Kailera’s portfolio of injectable, device/combination, and oral solid dose products
Lead drug substance and drug product development, process characterization, scale-up, and technology transfer
Drive CMC operational excellence and cost optimization across the product lifecycle
Direct analytical method development, qualification, validation, and transfer
Direct end-to-end device and combination product development, including platform selection, DHF ownership, design controls, risk management, verification, validation, and design transfer
Build and lead the human factors engineering strategy for combination products
Ensure compliance with applicable combination product, medical device, cGMP, quality system, and global regulatory requirements
Author and oversee CMC and device sections of regulatory submissions and represent CMC/device in health authority interactions
Partner with External Manufacturing on CDMO strategy, selection, and manufacturing capacity
Build, mentor, and lead the CMC and device engineering organization
Partner with Regulatory Affairs, Quality Assurance, Clinical Operations, Program/Portfolio Management, and Commercial
Own CMC and device risk management and supply continuity planning
Manage CMC budget, external spend, and vendor contracts
Report to the Chief Technology Officer and serve on the Technical Operations leadership team

Requirements

What you’ll need

15+ years of progressive CMC leadership experience in the 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, including design controls, design history files, risk management, and verification/validation activities
Working knowledge of ISO 11608, ISO 11040, ISO 10993, ISO 13485, ISO 14971, 21 CFR Part 4, and EU MDR Article 117
Experience with oral solid dose formulation development and injectable/parenteral products
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 and global commercial product supply chains
Experience managing CDMO and device supplier relationships, including technical oversight, platform evaluation, and contract/quality agreement negotiation
Excellent executive communication skills
Ability to collaborate cross-functionally with Regulatory, Quality, Clinical, and Commercial teams
Ability to operate in a growth-stage biotech while maintaining rigorous compliance and quality standards
Local candidates strongly preferred; relocation and remote talent considered
Remote employees must adhere to the Hub & Home working model, including a minimum of one week per month in the Waltham, MA corporate office
Overall work-related travel estimated at least 25%
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

Benefits

Comp & perks

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability insurance
Life insurance
Annual bonus opportunities
Equity grants