Senior Manager, Process Engineer - Drug Product

Praxis Precision Medicines, Inc.

6h • Remote

About The Position

Praxis is seeking a skilled and driven Process Engineer to partner closely with our Contract Manufacturing Organizations (CMOs) to validate and optimize drug product manufacturing processes—primarily oral dosage forms. You’ll play a key role in ensuring readiness for future commercial production and maintaining appropriate supply levels. The right candidate brings hands-on engineering expertise, excels in leading day-to-day CMO communication, and serves as a trusted point of contact for seamless knowledge transfer between Praxis and our manufacturing partners.

Requirements

• Advanced degree in chemical engineering, pharmaceutical sciences or other relevant engineering field, MS or equivalent a plus. Pharmaceutical industry experience required, e.g. process operations knowledge of sifting, milling, blending, roller compaction, tableting, coating among others.
• 8 years’ with a BS degree or 6 years’ with an MS degree of applied experience in CMO management, drug product manufacturing, or comparable positions that handle diverse 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

Responsibilities

• Ability to understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals.
• Efficient use of technologies and applications to gather, analyze and archive large data packages that can support regulatory filings.
• Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports.
• Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all our processes being executed by third parties.
• Adhere to industry guidelines, standards and laws including being well-versed in cGMPs.
• Travel required - PIP at CMOs (US and worldwide)

Benefits

• 99% of the premium paid for medical, dental and vision plans.
• company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
• dollar-for-dollar match up to 6% on eligible 401(k) contributions
• long-term stock incentives and ESPP
• discretionary quarterly bonus
• extremely flexible wellness benefit
• generous PTO
• paid holidays and company-wide shutdowns

What This Job Offers

• Job Type: Full-time
• Career Level: Senior