Senior API Process Engineer: Scale-Up & Tech Transfer

CordenPharma; Boulder (CO); Presencial; USD 101.000 - 126.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) matching

Health Insurance PPO/HSA

Tuition Reimbursement

Descripción de la vacante

CordenPharma, a leading CDMO, seeks a Sr. Chemical Process Engineer in Boulder, CO. The role focuses on developing and optimizing processes for complex small molecules and APIs, with emphasis on technology transfer and continuous improvement across manufacturing sites.

You will lead project teams, design scale-up strategies, and ensure compliance with FDA, cGMPs, EPA, OSHA, and PSM. A BS in Chemical Engineering and 7+ years in pharma manufacturing are required.

Formación

• BS in Chemical Engineering and 7 years of demonstrated success in process engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.
• Experience leading scale-up projects and technology transfers.
• Strong knowledge of FDA, cGMPs, EPA, OSHA, and PSM requirements.

Responsabilidades

• Lead complex process development for small molecules and peptides; drive scale-up from kilo to full production.
• Author SOPs, guidelines, PSI packages; develop process models and transfer packages.
• Lead technology transfer between manufacturing sites and implement innovative scale-up technologies.
• Perform process validation on API processes and ensure regulatory compliance.
• Identify and implement process improvements to reduce costs and improve yield and quality.

Conocimientos

Scale-up expertise

Process development

regulatory compliance

Project leadership

Chemical engineering math

Educación

BS in Chemical Engineering

Herramientas

Batch +

ChemE simulation software

Descripción del empleo

CordenPharma, a leading CDMO, seeks a Sr. Chemical Process Engineer in Boulder, CO. The role focuses on developing and optimizing processes for complex small molecules and APIs, with emphasis on technology transfer and continuous improvement across manufacturing sites.

You will lead project teams, design scale-up strategies, and ensure compliance with FDA, cGMPs, EPA, OSHA, and PSM. A BS in Chemical Engineering and 7+ years in pharma manufacturing are required.