cGMP Gene Therapy Production Engineer

Encoded Therapeutics, Inc.; Morrisville, Northern (NC, KY); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits package

PTO, sick time, and holidays

Generous parental leave

Pre-tax medical and dependent care

STD, LTD, Life and AD&D

Team-building events

Wellness resources

Job summary

Encoded Therapeutics, Inc. in Morrisville, NC, is seeking a Manufacturing Engineer to execute cGMP and non-cGMP gene therapy production campaigns.

You will contribute across CMC, Technology Transfer, Supply Chain and Quality with a focus on production execution. The role requires at least 2 years' cGMP biologics experience, strong cross-functional collaboration, and the ability to support multi-shift operations.

Qualifications

• Minimum of 2 years in a cGMP environment producing a biologic product.
• Strong cross-functional collaboration and teamwork.
• Excellent oral and written communication skills.
• Ability to manage time and priorities in a fast-paced setting.
• Willingness to support nights and weekends as needed.
• Up to 10% travel.

Responsibilities

• Execute end-to-end Batch Production from cell expansion to final filtration and dose aliquot preparation.
• Maintain a compliant manufacturing environment through documentation, equipment checks, and cleanliness.
• Perform real-time troubleshooting and escalate issues as needed.
• Author SOPs and Master Batch Records with QA.
• Own investigations, deviations, and CAPAs.
• Tech transfer to scale-up and implement processes.
• Support FAT/SAT and equipment validation and onboarding.
• Create training materials and provide internal/external site instruction.

Skills

Cross-functional collaboration

Communication

Adaptability

Multi-shift readiness

Education

B.S. in Engineering or Life Sciences

Job description

Encoded Therapeutics, Inc. in Morrisville, NC, is seeking a Manufacturing Engineer to execute cGMP and non-cGMP gene therapy production campaigns.

You will contribute across CMC, Technology Transfer, Supply Chain and Quality with a focus on production execution. The role requires at least 2 years' cGMP biologics experience, strong cross-functional collaboration, and the ability to support multi-shift operations.