Senior Manager, Process Engineer - Drug Product

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary:

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.

Primary 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)

Qualifications and Key Success Factors:

• 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

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.