Manufacturing Engineer - Gene Therapy Production

Core 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
• 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

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

Preferred Requirements

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