Senior Process Engineer — Remote, CMO API Scale-Up

Praxis Precision Medicines, Inc.; Northern (KY); A distancia; USD 110.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision plans (premium

Company-paid life insurance

AD&D

Disability benefits

401(k) matching up to 6%

Stock incentives/ESPP

PTO & holidays

Annual bonuses

Descripción de la vacante

Praxis Precision Medicines, Inc. is seeking a Process Engineer to collaborate with CMOs for the development and validation of API manufacturing processes. You will translate lab-scale chemistry into industrial workflows, review regulatory-relevant documents, and support knowledge transfer between Praxis and CMOs.

The role emphasizes strong communication, problem solving, and willingness to travel for PIP activities at CMOs around the world, ensuring robust supply and compliance.

Formación

• BS or MS in chemical engineering or related field; pharma experience a plus.
• 4–8 years in CMO management or chemical manufacturing, reviewing batch records and change controls.
• Excellent written and visual communication; ability to build relationships internally and externally.
• Self-motivated and collaborative team player.

Responsabilidades

• Translate lab-scale processes to industrialized scale by authoring scale-up spreadsheets and process manuals.
• Assemble and analyze large data packages for regulatory filings, archiving results.
• Review CMOs' documents: procedures, batch records, non-conformances, and change controls.
• Partner with Quality Assurance to ensure regulatory compliance in third-party processes.
• Adhere to cGMPs and industry guidelines; identify process risks and mitigation plans.
• Travel to CMOs and participate in in-person plant activities (US and worldwide).

Conocimientos

Written communication

Data analysis

Collaboration

Detail-oriented

Educación

Bachelor's or higher in chemical engineering

Descripción del empleo

Praxis Precision Medicines, Inc. is seeking a Process Engineer to collaborate with CMOs for the development and validation of API manufacturing processes. You will translate lab-scale chemistry into industrial workflows, review regulatory-relevant documents, and support knowledge transfer between Praxis and CMOs.

The role emphasizes strong communication, problem solving, and willingness to travel for PIP activities at CMOs around the world, ensuring robust supply and compliance.