Senior Director of API Development / Senior Directoress of API Development

Senior Director, API Development

Location: Permanent - Newark, CA

Are you an experienced leader in API Development 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. With significant investment to accelerate the growth of its pipeline, this organization is backed by a strong balance sheet, strategic partnerships with leading pharmaceutical companies, and a rapidly expanding portfolio, entering an exciting new phase of growth and scientific innovation.

Primary Responsibilities:

In this role, you will report to executive leadership and lead a multidisciplinary API Development function responsible for advancing peptide drug substances from early development through clinical and commercial manufacturing. You will be a key player in defining scalable synthetic routes, overseeing technology transfer activities, managing external manufacturing partners, and developing robust supply strategies to support global clinical programs. This is a highly visible leadership position with significant influence across various departments including Discovery, Preclinical Development, Analytical Sciences, Toxicology, CMC, and Regulatory Affairs.

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.

Responsibilities Include:

• Leading API process development activities for peptide therapeutics, non-canonical amino acids, and small molecule components.
• Developing phase-appropriate manufacturing routes using both solid-phase peptide synthesis (SPPS) and liquid-phase peptide synthesis (LPPS).
• Driving process optimization, scale-up, and technology transfer to global CDMO partners.
• Establishing manufacturing and supply strategies for raw materials, regulatory starting materials, and drug substances.
• Managing outsourced process development and manufacturing programs.
• Partnering closely with analytical development teams to understand impurity profiles and process performance.
• Supporting regulatory submissions, CMC documentation, and global health authority interactions.
• Building, mentoring, and leading a high-performing API Development organization.
• Identifying innovative technologies and manufacturing approaches to improve efficiency, quality, and scalability.

Compensation:

Salary: $250,000 - $280,000 p/a + Benefits

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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