Executive Director, API Development, Small Molecule

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. This role requires occasional travel (approximately 25%).