[Hiring] Senior Process Engineer @Praxis Precision Medicines, Inc.

Role Description

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

We are looking for a competent Process Engineer to work closely with our Contract Manufacturing Organizations (CMOs) in the field in order to support and validate processes related to the manufacture of small molecule Active Pharmaceutical Ingredients (APIs). You will also support future commercial production to help ensure appropriate supply levels are available. The ideal candidate is an engineer experienced with supporting day-to-day communications with the CMO as well as contributing to knowledge transfer activities between Praxis and the CMO.

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, certificates of analysis, and developmental reports.
• Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all processes being executed by third parties.
• Adhere to industry guidelines, standards and laws including being well-versed in cGMPs.
• Identify and escalate process risks and support development of mitigation plans.
• Travel required, participate in person-in-plant (PIP) activities at CMOs (US and worldwide).

Qualifications

• Bachelor’s or advanced degree in chemical engineering or other relevant engineering field; MS or equivalent a plus.
• Pharmaceutical or fine chemical industry experience required.
• 4–8 years of applied experience in CMO management, chemical manufacturing, or comparable positions that handle diverse chemical syntheses in laboratory and manufacturing environments.
• 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.
• Comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

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.
• Joining a phenomenal crew of colleagues who are smart, engaged and inspiring.

Company Description

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.

• Core Values: Trust, Ownership, Curiosity, and Results.
• Commitment to diversity, equity, and inclusion.