Senior Manager – Process Engineer, Drug Substance
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).
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.
Benefits:
• 99% of the premium paid for medical, dental and vision plans.
• Company-paid life insurance.
• AD&D.
• Disability benefits.
• Voluntary plans to personalize your coverage.
• 401(k) match dollar-for-dollar up to 6% on eligible contributions.
• Long-term stock incentives.
• ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO.
• Paid holidays.
• Company-wide shutdowns.
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• 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).
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.
Benefits:
• 99% of the premium paid for medical, dental and vision plans.
• Company-paid life insurance.
• AD&D.
• Disability benefits.
• Voluntary plans to personalize your coverage.
• 401(k) match dollar-for-dollar up to 6% on eligible contributions.
• Long-term stock incentives.
• ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO.
• Paid holidays.
• Company-wide shutdowns.
Apply tot his job
Apply To this Job