Senior Director, Peptide API Development & Scale-Up

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

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.