Executive Director, API Development, Small Molecule

Insmed Incorporated•NJ Corporate Headquarters, NJ

60d•$247,000 - $337,000•Remote

About The Position

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.

Requirements

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.
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 Haves

Experience with compounds used for inhalation and combination products

Responsibilities

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

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back