Executive Director, API Development, Small Molecule

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 five 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’re looking for an Executive Director, API Development, Small Molecule on the CMC Product Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President of Product Development – CMC, Small Molecule, you’ll lead the strategic direction of the API Development for the company’s small molecule pipeline within Technical Operations. You’ll oversee synthesis and process development activities for preclinical and clinical candidates, including laboratory experimentation for compound preparation. You will serve as a key advisor to executive leadership on development strategy, manufacturing technologies, and portfolio decisions, while building organizational capabilities and developing future leaders.

What You'll Do:

In this role, you’ll have the opportunity to drive cross-functional initiatives and external collaborations, fostering innovation, operational excellence, and a strong patient-focused culture. This role partners with leaders across Discovery, Clinical Development, Quality, Regulatory Affairs, Operations and Commercial teams to ensure seamless program advancement. You’ll also:

• Establish and execute the long-term vision, strategy, and operating model for API Development, ensuring alignment with portfolio objectives and corporate strategy
• Provide strategic leadership for API development, API process development, technology transfer, process validation, manufacturing readiness, and lifecycle management across development programs
• Serve as a key member of the Technical Operations leadership teams, influencing portfolio decisions, resource allocation, risk mitigation strategies, and investment priorities
• Direct the design and scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale-up
• Manage the science and engineering underlying the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies and products to achieve cost effectiveness and improved product quality
• Plan and implement the development of new process formulas, establishes operating equipment specifications and improves manufacturing techniques and new process equipment production
• Regularly interact with vendors, regulatory bodies and other external stakeholders exerting influence and negotiating to drive business results
• Represent the company externally through scientific publications, conference presentations, industry forums, advisory boards, and strategic collaborations
• Develop organizational talent through coaching, succession planning, leadership development, and creation of a high-performing and inclusive culture
• Establish enterprise metrics and performance frameworks that ensure execution excellence, accountability, and continuous improvement across the Pharmaceutical Development function

Who You Are:

You have a PhD along with 10 years of CMC experience or MS and 12 years of CMC experience or BS and 15 years of CMC experience within the pharmaceutical industry.

You are or you also have:

• Extensive expertise in route design, process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness for small molecule APIs
• A strong commitment to experimental work is essential, as well as the ability to independently identify and solve complex problems to advance projects through the development process
• Thorough understanding of cGxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements
• Experienced with authoring, reviewing and approving CMC sections of regulatory submissions including INDs, NDAs/MAAs and other required documentation
• Demonstrated track record of managing multiple programs, resources and staff from early discovery through commercialization
• Extensive expertise in working with CRO/CMO's both as a lead and a team member
• Track record of driving transformational change, organizational capability building, and continuous improvement initiatives
• Exceptional communication, negotiation, and influencing skills, including interactions with executive leadership, regulatory agencies, external partners, and scientific organizations

Nice to have (but not required):

• Experience with compounds used for inhalation and combination products

Where You’ll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This role requires occasional travel (approximately 25%).

#LI-REMOTE

#LI-MC1

Pay Range:

$247,000.00-337,000.00 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. 

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 TotalRewards@insmed.com  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.