Vice President, CMC Development and Drug Delivery Innovation
kailera
16 days ago
Full-time
On-site
US-Remote
$272,000 - $340,000 USD yearly
Executive
Moneyboard classification: Published range reaches threshold
Reported USD annual base: $272,000–$340,000
Original source: Greenhouse
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
Required Qualifications:
15+ years of progressive CMC leadership experience in the biotechnology or pharmaceutical industry, including 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 (autoinjector, prefilled syringe, or pen platforms), including design controls, design history files (DHF), risk management, and verification/validation activities
Working knowledge of ISO medical device standards (11608, 11040, 10993, 13485, 14971), 21 CFR Part 4, and EU MDR Article 117 requirements for combination products
Experience with oral solid dose formulation development in addition to injectable/parenteral products
Prior authorship and ownership of CMC sections for at least one BLA, NDA, or MAA submission, with direct experience interacting with FDA and
Reported USD annual base: $272,000–$340,000
Original source: Greenhouse
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
Required Qualifications:
15+ years of progressive CMC leadership experience in the biotechnology or pharmaceutical industry, including 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 (autoinjector, prefilled syringe, or pen platforms), including design controls, design history files (DHF), risk management, and verification/validation activities
Working knowledge of ISO medical device standards (11608, 11040, 10993, 13485, 14971), 21 CFR Part 4, and EU MDR Article 117 requirements for combination products
Experience with oral solid dose formulation development in addition to injectable/parenteral products
Prior authorship and ownership of CMC sections for at least one BLA, NDA, or MAA submission, with direct experience interacting with FDA and