Senior Manager - Process Engineer, Drug Substance

Role Summary

Senior Manager - Process Engineer, Drug Substance. Lead point of contact with Contract Manufacturing Organizations (CMOs) to validate small molecule API manufacturing processes, ensure successful tech transfer, and support commercial readiness. You’ll also oversee future production to maintain reliable supply, working onsite at partner facilities in a fast-moving, cross-functional environment. Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

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

• 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.