Vice President, CMC Development and Drug Delivery Innovation

The posting, as Kailera Therapeutics, Inc. wrote it

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 a

[…]
ement

• Experience scaling a CMC or Technical Operations function from a lean, pre-commercial organization
• Familiarity with global regulatory filings beyond the U.S. (e.g., EMA and other major health authorities)

Education

Advanced degree (Ph.D., or M.S./B.S. with equivalent industry experience) in chemistry, chemical engineering, pharmaceutical sciences, biomedical/mechanical engineering, or a related discipline.
Salary Range
$272,000 — $340,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify

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