Senior Director API Development

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

Job summary

Proclinical and a leading biotechnology company seek a Senior Director API Development to drive peptide API development from discovery through commercial manufacturing in Newark, CA. You will shape scalable routes and oversee technology transfer with external partners.

You will lead cross-functional teams across Discovery, Preclinical Development, Analytical Sciences, Toxicology, CMC and regulatory affairs, ensuring robust supply strategies for global programs.

Qualifications

• PhD in Organic Chemistry, Process Chemistry or related field.
• Extensive pharma/biotech process development experience.
• Expertise in peptide API development and manufacturing.
• Experience with SPPS and LPPS technologies.
• Experience with IND, NDA, IMPD submissions.
• Proven leadership of internal teams and external CDMO networks.
• Knowledge of FDA/EMA/ICH and cGMP requirements.
• Ability to influence cross-functional stakeholders in fast-paced env.

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.

Skills

PhD in Organic Chemistry

Process Chemistry

Peptide API development

SPPS/LPPS

Regulatory submissions (IND, NDA, IMPD

Leadership

CDMO management

FDA/EMA/cGMP knowledge

Education

PhD in Organic Chemistry or related field

Tools

SPPS equipment

LPPS equipment

Scale-up equipment

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.

Compensation

• $250,000 - $280,000 p/a + Benefits