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 ResponsibilitiesProduction & 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- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time, and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Stocked micro-kitchen with drinks and snacks
- Wellness Resources
