Encoded Therapeutics

Manufacturing Engineer - Gene Therapy Production

Morrisville, United States

Sponsorship not specifiedDetected 35 days ago

Supply ChainGMPCRISPRLeadershipCommunicationCollaborationAdaptability

About the role

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.
For more information, please visit www.encoded.com.

Process Troubleshooting - Perform real-time troubleshooting for batch processing issues and escalate to leadership as appropriate.
Technical Documentation 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.
Production Support 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
Adaptability - Strong ability to manage time and balance multiple priorities in a fast-paced environment.
Flexibility - Ability to support a multi-

Preferred Requirements Education - B.S. degree in an Engineering or a Life Sciences focused major.
Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic,
Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave.

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 driven by a mission to meaningfully improve the lives of patients and families affected by devastating neurological disorders.
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 across multiple facets of the business (for example, CMC, Technology Transfer, Supply Chain and Quality) with primary duties focused on production execution.

Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

This listing is sourced directly from Encoded Therapeutics's careers page and normalized into a canonical job model.