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