Executive Director API Development

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

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:

• $260,000 - $320,000 p/a + Benefits

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