Vice President, Product Development - CMC, Small Molecules

Vice President, Product Development - Cmc, Small Molecules

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we're in. Are you?

We are seeking a highly experienced and visionary Vice President, Product Development - Cmc, Small Molecules, to help us expand what's possible for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (Cmc) activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug product development, analytical development, and combination product development. To be successful in this position, you will be a strategic leader, ensuring that development programs meet scientific, quality, regulatory, and commercial standards, while ensuring execution across internal teams and external partners (Cdmo, Cmos).

As the Vice President, Product Development - Cmc, Small Molecules, you will provide strategic leadership by defining and executing the Cmc strategy for all small molecule programs throughout their lifecycle, from preclinical development through commercialization. You will serve as a key member of the Technical Operations leadership team and contribute significantly to our overall product development strategy. You'll lead both drug substance (Api) and drug product development initiatives, including formulation development, process chemistry, and scale-up operations. You will oversee analytical method development and validations and have experience in combination devices. A critical aspect of this role involves ensuring manufacturing readiness for both clinical and commercial supply chains.

Your responsibilities will include supporting global Cmc regulatory strategies that align with our clinical and commercial objectives. You will author, review, and approve Cmc sections of regulatory submissions including Inds, Ndas / Maas, and other required documentation. Ensuring compliance with Ich, Fda, Ema, Pmda and other international regulatory guidelines will be essential to your success. You will also build and lead a high-performing Cmc team while managing relationships with external manufacturing partners and Cdmos to ensure reliable clinical supply and maintain quality standards. Cross functional collaboration will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations, and Commercial teams to ensure seamless program advancement. You will also provide technical expertise and due diligence support for business development opportunities.

This role offers the opportunity to make a significant impact on our small molecule pipeline while leading a talented team in a dynamic biopharmaceutical environment.

Who You Are :

• Ph.D. or advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 15+ years of progressive experience in Cmc development for small molecule pharmaceuticals, with at least 7 years in senior leadership.
• Proven track record in advancing programs from preclinical to commercial launch.
• Deep knowledge of small molecule process chemistry, formulation, and analytical development.
• Demonstrated success in regulatory submissions and global Cmc regulatory requirements.
• Experience managing external partners (Cmos / Cdmos).
• Strong leadership, strategic thinking, and communication skills.

Where You'll Work This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Alternatively, if you live within a drivable distance of Bridgewater, NJ, you'll have the option to work remotely most of the time, but with more in-person collaboration when it matters most.

Travel Requirements This role requires occasional global travel (approximately 30%).