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?

About the Role:
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).

What You'll Do:

As the Vice President, Product Development - Chemistry, Manufacturing, and Controls (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%).

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Pay Range:
$329,000.00-398,326.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.