Senior Manager - Process Engineer, Drug Substance

About This Role

Serve as the lead Process Engineer to validate small molecule API manufacturing processes, ensure successful tech transfer, and support commercial readiness for Praxis's Contract Manufacturing Organizations (CMOs). Oversee future production to maintain reliable supply.

Responsibilities

• Understand chemical synthesis processes from lab partners and translate to industrialized execution by authoring scale up spreadsheets and process manuals
• Efficiently use technologies and applications to gather, analyze, and archive large data packages for regulatory filings
• Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, and developmental reports
• Work alongside Quality Assurance to ensure all proper regulations and standards are followed in processes executed by third parties
• Adhere to industry guidelines, standards, and laws, including cGMPs

Requirements

• Advanced degree in chemical engineering or other relevant engineering field
• 8 years with a BS degree or 6 years with an MS degree of applied experience in CMO management, chemical manufacturing, or comparable positions
• Pharmaceutical or fine chemical industry experience
• Experience handling diverse chemical syntheses in laboratory and manufacturing environments
• Experience reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls
• Excellent written and visual communication skills
• Ability to build relationships internally and externally
• Self-motivated
• Highly organized and detail-oriented

Qualifications

• Advanced degree in chemical engineering or other relevant engineering field, MS or equivalent a plus
• 8 years with a BS degree or 6 years with an MS degree of applied experience in CMO management, chemical manufacturing, or comparable positions

Nice to Have

• MS degree in chemical engineering or equivalent

Benefits