Peptide API Development Leader — Scale-Up & Tech Transfer

Proclinical Staffing; Newark (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Proclinical Staffing is partnering with a leading biotechnology company in Newark, CA, seeking a Senior Director of API Development to lead peptide API development from early development through clinical and commercial manufacturing.

You will define scalable synthetic routes, manage external CDMOs, and develop robust supply strategies to support global clinical programmes in a highly visible leadership role.

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 and drug substances.
• Manage outsourced process development and manufacturing programmes; partner with analytical teams.
• Support regulatory submissions, CMC documentation and regulatory interactions.
• Build and mentor a high-performing API Development organisation.
• Identify innovative technologies to improve efficiency, quality and scalability.

Skills

Leadership

Process development

Regulatory strategy

Scale-up

CDMO management

IND/NDA submissions

SPPS/LPPS

Education

PhD in Organic Chemistry, Process Chemistry or related discipline

Job description

Proclinical Staffing is partnering with a leading biotechnology company in Newark, CA, seeking a Senior Director of API Development to lead peptide API development from early development through clinical and commercial manufacturing.

You will define scalable synthetic routes, manage external CDMOs, and develop robust supply strategies to support global clinical programmes in a highly visible leadership role.