Manufacturing Engineer - Gene Therapy Production

Encoded Therapeutics•Morrisville, NC

21h

About The Position

Encoded Therapeutics is a clinical-stage biotechnology company developing precision genetic medicines to transform the lives of patients with severe neurological disorders. The company’s vector engineering platform enables potent and cell-type-selective regulation of gene expression, allowing for targeted modulation of disease-relevant genes. Encoded is advancing a pipeline of programs across genetic epilepsies and other neurological disorders with significant unmet need. With integrated discovery, development, and manufacturing capabilities, Encoded is positioned to efficiently move programs from concept through the clinic. Encoded is driven by a mission to meaningfully improve the lives of patients and families affected by devastating neurological disorders. For more information, please visit www.encoded.com. We are seeking a mission-driven Manufacturing Engineer to execute critical production runs across both cGMP and non-cGMP Gene Therapy campaigns. This role offers a unique opportunity to contribute to a high-growth environment, supporting everything from technology transfer to full-scale batch disposition and product lifecycle management.

Requirements

Industry Experience: Minimum of 2 years of direct experience in a cGMP environment producing a biologic product.
Collaboration: Proven cross-functional collaborator and teammate.
Communication: Excellent oral and written communication skills.
Adaptability: Strong ability to manage time and balance multiple priorities in a fast-paced environment.
Flexibility: Ability to support a multi-shift operation that covers nights and weekends as needed.
Travel: Ability to travel up to 10%.
Physical: Ability to lift and/or move up to 25 pounds regularly and occasionally up to 50 pounds.

Nice To Haves

Education: B.S. degree in an Engineering or a Life Sciences focused major.
Technical Expertise: 1+ years of proficiency in batch production.

Responsibilities

Execute Batch Production: Perform end-to-end batch operations, including solution preparation and major unit operations from cell expansion through final filtration, bottling, and dose aliquot preparation
Maintain Quality: Ensure a compliant manufacturing environment through documentation execution, waste disposal, equipment checks, instrument standardization, and facility cleanliness.
Process Troubleshooting: Perform real-time troubleshooting for batch processing issues and escalate to leadership as appropriate.
Author Process Records: Develop and maintain Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) in partnership with Process Sciences and Quality assurance (QA).
Manage Exceptions: Own manufacturing investigations, including deviation root-cause analysis, change controls, and CAPAs.
Tech Transfer: Assess incoming products against existing infrastructure to ensure successful scale-up and process implementation.
Operational Readiness: Partner with Supply Chain and Process Sciences to identify preferred materials to ensure readiness across various processing scales.
Equipment Validation and Onboarding: Support Factory/Site Acceptance Testing (FAT/SAT) as well as equipment commissioning and validation protocols.
Knowledge Sharing: Create training materials and provide instruction for internal and external manufacturing sites while maintaining individual training compliance