Senior Process Engineer, Pharma API — Remote/Travel

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 110,000 - 125,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking a Process Engineer to collaborate with CMOs on API manufacturing processes and support future commercial production.

You will translate lab processes into scale-up instructions, manage data for regulatory filings, and work with QA to ensure cGMP compliance while traveling to CMOs as needed. The role requires 4–8 years in chemical manufacturing or CMO environments, strong communication skills, and a proactive, detail-oriented mindset.

Qualifications

• Bachelor’s or advanced degree in chemical engineering or related field.
• 4–8 years of experience in CMO management, chemical manufacturing, or comparable roles.
• Experience reviewing manufacturing and executed batch records, SOPs, non-conformances and change controls.
• Excellent written and visual communication skills to build internal and external relationships.
• Willingness to travel for in-plant activities at CMOs (US and worldwide).

Responsibilities

• Translate lab synthesis processes into industrialized execution by authoring scale-up spreadsheets and process manuals.
• Gather, analyze and archive large data packages to support regulatory filings.
• Review CMOs and lab partner documentation including batch records, instructions and development reports.
• Work with Quality Assurance to ensure compliance with regulations and standards in third-party processes.
• Adhere to cGMPs and other industry guidelines and laws.
• Identify process risks and support development of mitigation plans.
• Travel to CMOs for in-person plant activities as needed.

Skills

Strong communication

Process scale-up

Regulatory documentation

Data analysis

Travel readiness

Education

Bachelors or advanced degree in chemical engineering

MS or equivalent (plus)

Job description

Praxis Precision Medicines, Inc. is seeking a Process Engineer to collaborate with CMOs on API manufacturing processes and support future commercial production.

You will translate lab processes into scale-up instructions, manage data for regulatory filings, and work with QA to ensure cGMP compliance while traveling to CMOs as needed. The role requires 4–8 years in chemical manufacturing or CMO environments, strong communication skills, and a proactive, detail-oriented mindset.