Vice President, CMC Development and Drug Delivery Innovation

Kailera Therapeutics; Waltham (MA); Híbrido; USD 250.000 - 450.000; Jornada completa

Descripción de la vacante

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,

Responsabilidades

• 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

Descripción del empleo

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

Kailera Therapeutics is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1-based therapies for people living with obesity, including ribupatide (an injectable, once-weekly GLP-1/GIP dual agonist currently in global Phase 3 trials), an oral formulation of ribupatide, KAI-7535 (an oral GLP-1 receptor agonist), and KAI-4729 (an injectable GLP-1/GIP/glucagon tri-agonist).

The Vice President, CMC Drug & Device Development will own Chemistry, Manufacturing, and Controls (CMC) strategy and execution across this portfolio - spanning drug substance, drug product, device and combination product development, and oral solid dose formulation. This is a highly cross-functional, build-and-run leadership role responsible for advancing Kailera's pipeline from late-stage clinical development through regulatory filing and toward commercial launch readiness.

Reporting to the Chief Technology Officer, the VP will lead a growing CMC organization and serve as a key member of the Technical Operations leadership team, partnering closely with Regulatory Affairs, Quality, Clinical Development, and Commercial to ensure a robust, compliant, and scalable supply chain for Kailera's medicines.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

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