Focused patient recruitment.

Senior Manager – Process Engineer, Drug Substance

EngineerEngineerFull TimeRemoteTeam 11-50Since 2002H1B SponsorCompany Site LinkedIn

Location

United States

Posted

36 days ago

Salary

$160K - $180K / year

Postgraduate Degree8 yrs expEnglish

Job Description

• Serve as Praxis’s lead point of contact with our Contract Manufacturing Organizations (CMOs). • Work onsite at partner facilities to validate small molecule API manufacturing processes. • Ensure successful tech transfer and support commercial readiness. • Oversee future production to maintain reliable supply. • Understand written chemical synthesis processes and translate those to instructions for industrialized execution. • Efficiently gather, analyze, and archive data to support regulatory filings. • Review documentation from CMOs and lab partners including instructions, procedures, and batch records. • Work alongside Quality Assurance to ensure follow of regulations and standards in all processes executed by third parties. • Adhere to industry guidelines and standards including cGMPs. • Travel required - PIP at CMOs (US and worldwide).

Job Requirements

Advanced degree in chemical engineering or other relevant engineering field, MS or equivalent a plus. Pharmaceutical or fine chemical industry experience required.
8 years’ with a BS degree or 6 years’ with an MS degree of applied experience in CMO management, chemical manufacturing, or comparable positions that handle diverse chemical syntheses in laboratory and manufacturing environments, reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls, and fostering business partner relationships.
Excellent written and visual communication skills with an ability to build relationships internally and externally.
Self-motivated and able to contribute to a productive and collaborative team environment.
Highly organized and detail-oriented with a passion to deliver quality results.