Senior Director API Development

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

Senior Director API Development's - Permanent - Newark, CA

Are you an experienced API Development leader looking to shape the future of peptide-based medicines?

Proclinical is partnering with a highly successful, publicly listed biotechnology company that has recently achieved multiple major regulatory and commercial milestones, including FDA approvals for innovative peptide therapeutics and significant investment to accelerate the growth of its pipeline. Backed by a strong balance sheet, strategic partnerships with leading pharmaceutical companies, and a rapidly expanding portfolio, the organisation is entering an exciting new phase of growth and scientific innovation. As part of this expansion, we are seeking a Senior Director, API Development to lead process research, development, scale-up and manufacturing strategy for a portfolio of cutting-edge peptide therapeutics.

Primary Responsibilities:

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.

You will play a key role in defining scalable synthetic routes, overseeing technology transfer activities, managing external manufacturing partners, and developing robust supply strategies to support global clinical programmes. This is a highly visible leadership position with significant influence across Discovery, Preclinical Development, Analytical Sciences, Toxicology, CMC, Regulatory Affairs and external CDMO partners.

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.

The Senior Director API Development's responsibilities will be:

• 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 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 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 organisation.
• Identify innovative technologies and manufacturing approaches to improve efficiency, quality and scalability.