Senior Director, Peptide API Development & Manufacturing

Proclinical; Town of Newark (WI); On-site; USD 260,000 - 320,000; Full time

Job summary

Proclinical is partnering with a biotechnology company seeking a Senior Director of API Development to lead process research, development, scale-up, and manufacturing strategy for peptide therapeutics. You will oversee internal teams and external CDMOs, shaping scalable routes for early development through commercial manufacturing.

You will drive IND/NDA/IMPD submissions, risk assessments, and regulatory interactions while partnering with analytical, regulatory, and CMC functions to ensure

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 both 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 development 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.

Skills

Leadership

Regulatory submissions

CDMO management

Cross-functional collaboration

IND/NDA/IMPD experience

Regulatory affairs

Process development leadership

Education

PhD in Organic Chemistry/Process Chemistry or related

Tools

SPPS

LPPS

Job description

Proclinical is partnering with a biotechnology company seeking a Senior Director of API Development to lead process research, development, scale-up, and manufacturing strategy for peptide therapeutics. You will oversee internal teams and external CDMOs, shaping scalable routes for early development through commercial manufacturing.

You will drive IND/NDA/IMPD submissions, risk assessments, and regulatory interactions while partnering with analytical, regulatory, and CMC functions to ensure