Senior Manager - Process Engineer, Drug Substance

Location: United States - Remote

Department: CMC

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking a skilled and hands-on Process Engineer to serve as Praxis’s lead point of contact with our Contract Manufacturing Organizations (CMOs). You’ll work onsite at partner facilities to validate small molecule API manufacturing processes, ensure successful tech transfer, and support commercial readiness. You’ll also play a key role in maintaining reliable supply by overseeing future production. The ideal candidate combines strong technical fundamentals with clear, proactive communication, and thrives in a fast-moving, cross-functional environment.

Primary Responsibilities

• Ability to understand written chemical synthesis processes from lab partners and help translate those to instructions 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 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
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

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.