Vice President, CMC & Drug-Delivery Innovation

Kailera Therapeutics; Waltham (MA); Hybrid; USD 250,000 - 450,000; Full time

Job summary

Kailera Therapeutics is a late clinical-stage biotechnology company advancing GLP-1-based therapies for obesity. The Vice President, CMC Drug & Device Development will own the strategy and execution across drug substance, drug product, device and combination products, spanning late-stage development to regulatory filing and commercial launch readiness.

Reporting to the Chief Technology Officer, the VP will lead a growing CMC organization and collaborate with Regulatory Affairs, Quality,

Responsibilities

• Own the CMC strategy for Kailera's full portfolio, including injectable drug product and device/combination products (autoinjector/prefilled pen platforms) and oral solid dose formulations, aligned to program timelines and business priorities
• Lead drug substance and drug product development, process characterization, scale-up, and technology transfer to clinical and support commercial manufacturing sites and CDMO partners
• Drive CMC operational excellence and cost optimization across the product lifecycle, including process optimization, yield, cycle time, and COGS
• Direct analytical method development, qualification, and validation across drug substance, drug product, and combination product testing, ensuring methods are robust, stability-indicating where required, and transfer-ready for CDMO and commercial manufacturing sites
• Direct device and combination product development end to end, including platform/device selection (evaluating commercially available autoinjector and pen platforms), design history file (DHF) ownership, design controls, risk management, verification and validation, and design transfer to manufacturing
• Build and lead the human factors engineering strategy for combination products, including formative and summative usability studies that inform design decisions and support regulatory submissions
• Ensure combination product compliance with 21 CFR Part 4, ISO 11608 (needle-based injection systems), ISO 11040 (prefilled syringes), ISO 10993 (biocompatibility), ISO 13485 (device quality systems), ISO 14971 (risk management), and EU MDR Article 117 for markets outside the U.S.
• Author and oversee CMC and device sections of regulatory submissions (IND/CTA amendments, End-of-Phase 2 and Pre-BLA/NDA meeting packages, BLA/NDA/MAA), and represent CMC/device in interactions with FDA and other health authorities globally
• Partner closely with the VP, External Manufacturing to shape and execute Kailera's CDMO manufacturing strategy, CDMO selection, aligning drug substance, drug product, and device manufacturing capacity with clinical and commercial supply needs
• Build, mentor, and lead a high-performing CMC and device engineering organization, adding functional depth (process development, analytical development, device/human factors engineering, CMC regulatory, supply chain) as the company scales toward commercialization
• Partner cross-functionally with Regulatory Affairs, Quality Assurance, Clinical Operations, Program/Portfolio Management, and Commercial to align CMC and device deliverables with clinical and launch timelines
• Own CMC and device risk management and supply continuity planning, including raw material, drug substance, and device component sourcing, capacity planning, and contingency strategies
• Manage the CMC budget, external spend, and vendor contracts in partnership with Finance and Procurement
• Ensure ongoing compliance with cGMP, quality systems (change control, deviations, inspection readiness), and applicable global regulations across the drug and device supply chain

Job description

Kailera Therapeutics is a late clinical-stage biotechnology company advancing GLP-1-based therapies for obesity. The Vice President, CMC Drug & Device Development will own the strategy and execution across drug substance, drug product, device and combination products, spanning late-stage development to regulatory filing and commercial launch readiness.

Reporting to the Chief Technology Officer, the VP will lead a growing CMC organization and collaborate with Regulatory Affairs, Quality,