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. Please note: this position is based in Morrisville, North Carolina, and relocation assistance is not available for this role. **Core Responsibilities** **Production & Operations** - 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. **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 **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. **Benefits** - Health Care Plan (Medical, Dental & Vision) - Retirement Plan (401k) - Life Insurance (Basic, Voluntary & AD&D) - Paid Time Off (Vacation, Sick & Public Holidays) - Family Leave: (Maternity, Paternity) - Short Term & Long Term Disability - Training & Development - Stocked micro-kitchen with drinks and snacks - Wellness Resources Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.