Senior Process Engineer, Drug Substance

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
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 and Key Success Factors
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, including reviewing manufacturing and executed batch records, operating procedures, non-conformances, and change controls, and supporting 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.