cGMP Gene Therapy Manufacturing Engineer

Encoded Therapeutics Inc.; Morrisville (NC); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

Stock option grants

Paid time off

Parental leave

Wellness resources

Résumé du poste

Encoded Therapeutics Inc. is seeking a Manufacturing Engineer in Morrisville, NC to execute end-to-end batch production for gene therapy campaigns.

You will maintain a compliant environment, troubleshoot issues, and collaborate with QA, Process Sciences and Supply Chain to enable scale-up and readiness across processing scales. The role requires 2+ years in a cGMP setting producing biologics, strong communication, and the ability to work across shifts including nights and weekends.

Qualifications

• Minimum of 2 years in a cGMP environment producing a biologic product.
• Strong cross-functional collaboration and communication skills.
• Ability to manage multiple priorities in a fast-paced setting.
• Willing to work a multi-shift operation including nights and weekends.
• Travel up to 10%.

Responsabilités

• Execute end-to-end batch production from cell expansion to final filtration and dose aliquot preparation.
• Maintain a compliant manufacturing environment through documentation, waste disposal, equipment checks, and facility cleanliness.
• Troubleshoot batch processing issues and escalate as needed.
• Author Process Records, SOPs and Master Batch Records with Process Sciences and QA.
• Own manufacturing investigations including deviation root-cause analysis, change controls, and CAPAs.
• Tech Transfer to assess incoming products against existing infrastructure for scale-up.
• Support equipment validation, FAT/SAT, and commissioning; train internal and external sites.

Connaissances

Cross-functional collaboration

Excellent written and verbal comms

Time management

Adaptability

Flexible schedule

Travel up to 10%

Team player

Formation

B.S. in Engineering or Life Sciences

Description du poste

Encoded Therapeutics Inc. is seeking a Manufacturing Engineer in Morrisville, NC to execute end-to-end batch production for gene therapy campaigns.

You will maintain a compliant environment, troubleshoot issues, and collaborate with QA, Process Sciences and Supply Chain to enable scale-up and readiness across processing scales. The role requires 2+ years in a cGMP setting producing biologics, strong communication, and the ability to work across shifts including nights and weekends.