Senior Process Engineer, Drug Substance

The role

You will work with Contract Manufacturing Organizations to support and validate processes for small molecule Active Pharmaceutical Ingredients. You will also support future commercial production and manage communications and knowledge transfer with CMOs.

What you will do

• Translate written chemical synthesis processes into scale-up spreadsheets and process manuals
• Use technologies to gather, analyze and archive data packages for regulatory filings
• Review documentation from CMOs and lab partners including batch records and certificates of analysis
• Work with Quality Assurance to ensure regulations and standards are followed
• Adhere to industry guidelines, standards and cGMPs
• Identify and escalate process risks and support mitigation plans
• Participate in person-in-plant activities at CMOs

Required qualifications

• Bachelor’s or advanced degree in chemical engineering or other relevant engineering field
• Pharmaceutical or fine chemical industry experience
• 4–8 years of applied experience in CMO management, chemical manufacturing, or comparable positions
• Experience reviewing manufacturing and executed batch records, operating procedures, non-conformances, and change controls
• Experience supporting business partner relationships
• Excellent written and visual communication skills
• 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

Nice to have

• MS or equivalent

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans to personalize coverage
• 401(k) matching dollar-for-dollar up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Extremely flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.