Senior Process Engineer, Drug Substance

About the role

Work closely with contract manufacturers to support and validate small molecule API production processes. The role also helps secure supply for future commercial manufacturing.

What you will do

• Turn written chemical synthesis routes from lab partners into scale-up spreadsheets and process manuals
• Gather, analyse and archive large data sets that support regulatory filings
• Review manufacturer and partner documents such as batch records, procedures and certificates of analysis
• Partner with Quality Assurance so third parties follow all rules and standards
• Follow industry guidelines and laws, including cGMPs
• Support day-to-day communication and knowledge transfer with contract manufacturers

What they look for

• Engineering experience supporting daily communication with contract manufacturers
• Able to interpret chemical synthesis processes and translate them for industrial execution
• Skilled at using technology to handle large data packages
• Familiar with cGMPs and industry standards and regulations
• Willing to travel as needed