Process Development Engineer – Drug Substance Technology

About the role

We are looking for a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. The role supports technology transfer and scale‑up of human therapeutic drug substance processes from clinical development through commercial manufacturing.

Key responsibilities

• Transfer and scale‑up drug substance processes for both stainless‑steel and single‑use platforms.
• Provide technical support for clinical and commercial manufacturing runs, including troubleshooting and data trending.
• Prepare and author technical reports, process characterization documents, and support CAPA and change‑control activities.
• Collaborate with Manufacturing, Quality, Analytical and bench scientists to ensure successful technology transfer.
• Identify and drive process‑related operational excellence opportunities.

Required profile

• Master’s degree in Chemical or Biochemical Engineering (or equivalent) with at least 2 years of process engineering experience, or comparable experience as outlined in the basic qualifications.
• Experience in biologics downstream/purification processes and technology transfer into cGMP facilities.
• Strong analytical, troubleshooting and problem‑solving abilities.
• Excellent written and verbal communication skills.

Required skills

• Process engineering and technology transfer
• Scale‑up of upstream (cell culture/bioreactor) and downstream (chromatography, viral filtration, ultrafiltration/diafiltration, final fill) processes
• Good Manufacturing Practice (GMP) knowledge
• Process characterization and data analysis
• Technical report writing
• CAPA and change‑control management