Manufacturing Engineer - cGMP Gene Therapy Production

About the role

Encoded Therapeutics is a clinical-stage biotechnology company developing precision genetic medicines for severe neurological disorders. It is seeking a Manufacturing Engineer to run critical production runs across cGMP and non-cGMP gene therapy campaigns, with duties focused on production execution. The role is based on site in Morrisville, North Carolina, and relocation assistance is not available.

Key responsibilities

• Perform end-to-end batch operations, from solution preparation and major unit operations through cell expansion, filtration, bottling and dose aliquot preparation
• Maintain a compliant manufacturing environment through documentation, waste disposal, equipment checks, instrument standardization and facility cleanliness
• Troubleshoot batch processing issues in real time and escalate to leadership as appropriate
• Develop and maintain SOPs and Master Batch Records with Process Sciences and QA, and own investigations including deviation root-cause analysis, change controls and CAPAs
• Assess incoming products against existing infrastructure for successful scale-up and process implementation
• Partner with Supply Chain and Process Sciences to identify preferred materials for operational readiness
• Support FAT/SAT, equipment commissioning and validation protocols, and create training materials for internal and external sites

Required profile

• Minimum 2 years of direct experience in a cGMP environment producing a biologic product
• Proven cross-functional collaboration and excellent oral and written communication
• Ability to manage multiple priorities in a fast-paced environment and to support night and weekend shifts
• Ability to travel up to 10% and to lift up to 25 pounds regularly, 50 pounds occasionally
• B.S. in Engineering or Life Sciences and 1+ year of batch production proficiency preferred

What we offer

• Comprehensive benefits with competitive employer premium contributions
• Stock option grants, PTO, sick time and holiday pay
• Parental leave, pre-tax medical and dependent care programs, and life insurance
• Professional development, team-building events, wellness resources and a stocked micro-kitchen