Senior Director, Peptide API Development & Manufacturing

Proclinical Group; Town of Newark (WI); On-site; USD 250,000 - 280,000; Full time

Job summary

Proclinical, a leading biotechnology firm, seeks a Senior Director API Development to lead peptide API development from early development through commercial manufacturing. The role oversees process research, scale-up, and tech transfer while coordinating with external CDMOs and regulatory teams.

You will define scalable routes for SPPS/LPPS, manage partnerships, and drive supply strategies to support global clinical programs.

Qualifications

• 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.

Responsibilities

• Lead API process development activities for peptide therapeutics, non-canonical amino acids and small molecule components.
• Develop phase-appropriate manufacturing routes using SPPS and LPPS.
• Drive process optimisation, 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 programmes.
• Partner with analytical 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 organisation.
• Identify innovative technologies and manufacturing approaches to improve efficiency, quality and scalability.

Education

PhD in Organic Chemistry/Process Chemistry

Tools

SPPS & LPPS

Job description

Proclinical, a leading biotechnology firm, seeks a Senior Director API Development to lead peptide API development from early development through commercial manufacturing. The role oversees process research, scale-up, and tech transfer while coordinating with external CDMOs and regulatory teams.

You will define scalable routes for SPPS/LPPS, manage partnerships, and drive supply strategies to support global clinical programs.