Senior Manager, Process Engineer

View full description

Requirements:

• Advanced degree in chemical engineering or a relevant engineering field; MS or equivalent preferred.
• 8 years of experience with a BS degree or 6 years with a MS degree in CMO management or chemical manufacturing.
• Strong understanding of chemical synthesis processes and experience reviewing manufacturing documentation.
• Excellent written and visual communication skills for building relationships.
• Self-motivated, organized, detail-oriented, and passionate about quality results.

Responsibilities:

• Work closely with Contract Manufacturing Organizations (CMOs) to validate processes related to manufacturing small molecule Active Pharmaceutical Ingredients (APIs).
• Oversee future commercial production to ensure appropriate supply levels.
• Lead day-to-day communications with CMOs and act as the Point of Contact for information transfer.
• Author scale up spreadsheets and process manuals based on lab partner instructions.
• Analyze and archive large data packages to support regulatory filings.
• Review documentation from CMOs and lab partners, ensuring adherence to industry guidelines and standards.