Encoded

Encoded

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.

Responsibilities

  • 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-

Requirements

  • Technical Expertise - 1+ years of proficiency in batch production.

Benefits

  • 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.

Company info

  • 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

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