Executive Director API Development

Shape the Future of Peptide-Based Medicines

Join a highly successful, publicly listed biotechnology company that has recently achieved major regulatory and commercial milestones, including FDA approvals for innovative peptide therapeutics. Backed by a strong balance sheet, strategic partnerships with leading pharmaceutical companies, and a rapidly expanding portfolio, the organization is entering an exciting new phase of growth and scientific innovation.

As a Senior Director, API Development, you will lead process research, development, scale-up, and manufacturing strategy for a portfolio of cutting-edge peptide therapeutics. Reporting into executive leadership, you will lead a multidisciplinary API Development function responsible for advancing peptide drug substances from early development through clinical and commercial manufacturing.

This is a highly visible leadership position with significant influence across Discovery, Preclinical Development, Analytical Sciences, Toxicology, CMC, Regulatory Affairs, and external CDMO partners.

Primary Responsibilities

• Lead API process development activities for peptide therapeutics, non-canonical amino acids, and small molecule components.
• Develop phase-appropriate manufacturing routes using both solid-phase peptide synthesis (SPPS) and liquid-phase peptide synthesis (LPPS).
• Drive process optimization, scale-up, and technology transfer to global CDMO partners.
• Establish manufacturing and supply strategies for raw materials, regulatory starting materials, and drug substances.
• Manage outsourced process development and manufacturing programs.
• Partner closely with analytical development teams to understand impurity profiles and process performance.
• Support regulatory submissions, CMC documentation, and global health authority interactions.
• Build, mentor, and lead a high-performing API Development organization.
• Identify innovative technologies and manufacturing approaches to improve efficiency, quality, and scalability.

Skills & Requirements

• PhD in Organic Chemistry, Process Chemistry, or a related scientific discipline.
• Significant pharmaceutical or biotechnology process development experience.
• Deep expertise in peptide API development and manufacturing.
• Strong hands-on knowledge of SPPS and LPPS technologies.
• Experience supporting IND, NDA, IMPD, and other global regulatory submissions.
• Demonstrated leadership of internal teams and external CDMO networks.
• Strong understanding of FDA, EMA, ICH, and cGMP requirements.
• Proven ability to influence cross-functional stakeholders in a fast-paced development environment.

Compensation

$260,000 - $320,000 p/a + Benefits