Executive Director, API Development

Executive Director, API Development

About the Company

Highly successful publicly listed biotechnology company advancing peptide therapeutics and expanding its pipeline

Industry
Biotechnology

Type
Public Company

About the Role

The Company is seeking an Executive Director of API Development to lead a multidisciplinary function advancing peptide drug substances from early development through clinical and commercial manufacturing. Responsibilities include defining scalable synthetic routes, optimizing processes, overseeing scale-up and technology transfer, and establishing manufacturing and supply strategies. The role also manages external manufacturing partners and outsourced programs, supports regulatory submissions and health authority interactions, and collaborates across scientific, development, quality, and regulatory teams. The leader will build and mentor a high-performing organization and identify approaches to improve manufacturing efficiency, quality, and scalability. Candidates should hold a PhD in Organic Chemistry, Process Chemistry, or a related scientific discipline, with substantial pharmaceutical or biotechnology process development experience. Deep expertise in peptide API development and manufacturing, including hands-on knowledge of solid-phase and liquid-phase peptide synthesis, is required. Applicants should have experience supporting global regulatory submissions and a strong understanding of applicable regulatory and cGMP requirements. Demonstrated leadership of internal teams and external manufacturing partners, along with the ability to influence cross-functional stakeholders in a fast-paced environment, is essential.

Functions

• Engineering