Vice President, CMC Development and Drug Delivery Innovation

OpenKrill; United States; On-site; USD 300,000 - 450,000; Full time

Job summary

Kailera Therapeutics is seeking a VP, CMC Drug & Device Development to own strategy across drug substance, product, device, and combination products. The role partners with Regulatory, Quality, Clinical Development, and Commercial to ensure robust, scalable supply chains and regulatory readiness.

The leader will build a growing CMC organization, interact with FDA/global health authorities, and drive technology transfer to CDMOs while aligning with milestone timelines and launch readiness.

Qualifications

• 15+ years in CMC leadership in biotech/pharma.
• 7+ years in senior leadership with drug substance/product development.
• Experience with injectable combination products and devices.

Responsibilities

• Own CMC strategy for full portfolio and device platforms.
• Lead drug substance/product development and technology transfer.
• Drive CMC cost optimization and process improvements.
• Oversee regulatory submissions and interactions with authorities.
• Build and mentor CMC and device engineering teams.
• Ensure 21 CFR Part 4 and ISO compliance.

Skills

CMC leadership

Device development

Regulatory collaboration

Cross-functional leadership

Strategic planning

Tools

CDMO management

Job description

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/or other health authorities on CMC and device matters
• - Proven track record building, leading, and scaling technical teams, including establishing global commercial product supply chains
• - Experience managing CDMO and device supplier relationships, including technical oversight, platform evaluation, and contract/quality agreement negotiation
• - A hands-on operator who is equally comfortable setting long-range CMC strategy and rolling up their sleeves on day-to-day execution in a lean, fast-moving organization
• - Excellent executive communication skills, with the ability to represent CMC clearly and credibly to the executive team, board of directors, and external partners and investors
• - A collaborative, cross-functional leader who builds trust quickly with Regulatory, Quality, Clinical, and Commercial counterparts
• - Comfortable operating with the ambiguity and resource constraints typical of a growth-stage biotech, while maintaining rigorous compliance and quality standards
• - A talent builder who can attract, develop, and retain strong technical leaders as the organization scales
• - Local candidates are strongly preferred; relocation and remote talent will be 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 (in addition to any other work-related travel), with overall work-related travel estimated at least 25%

Preferred Qualifications:

• - Experience in obesity, metabolic, or cardiometabolic therapeutic areas, particularly with GLP-1 or peptide-based therapeutics
• - Prior experience at a late clinical-stage biotechnology company transitioning toward commercial launch, including launch readiness and post-approval lifecycle management
• - Experience scaling a CMC or Technical Operations function from a lean, pre-commercial organization
• - Direct experience with Class III or implantable device regulatory requirements, or in vitro diag