Manufacturing Engineer - cGMP Gene Therapy Production
Encoded Therapeutics
Summary
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.
Job description
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
- Minimum of 2 years of direct experience in a cGMP environment producing a biologic product
- Proven cross-functional collaborator and teammate
- Excellent oral and written communication skills
- Strong ability to manage time and balance multiple priorities in a fast-paced environment
- Ability to support a multi-shift operation that covers nights and weekends as needed
- Ability to travel up to 10%
- Ability to lift and/or move up to 25 pounds regularly and occasionally up to 50 pounds
- B.S. degree in an Engineering or a Life Sciences focused major
- 1+ years of proficiency in batch production
Benefits
- Competitive employer premium contributions
- Stock option grants
- PTO
- Sick time
- Holiday pay
- 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
- Wellness resources
Company overview
Encoded Therapeutics is a clinical-stage biotechnology company pioneering precision genetic medicines for severe central nervous system (CNS) disorders. Founded in 2014 and headquartered in South San Francisco, California, the company is developing potentially disease-modifying gene therapies for pediatric CNS conditions using its proprietary vector engineering platform. Encoded's innovative approach combines novel regulatory elements and payloads with AAV vectors to achieve unprecedented gene specificity and cell selectivity, enabling targeted expression of therapeutic transgenes in specific cell types. The company's flagship program, ETX101, targets Dravet syndrome and has received RMAT designation from the FDA. Encoded's pipeline also includes programs for Angelman syndrome, Lennox-Gastaut syndrome, STXBP1-related disorders, Alzheimer's disease, and neuropathic pain. With a team of 51-200 employees and significant venture backing including a $135 million Series D round, Encoded is advancing potentially transformative one-time gene therapies that could address significant unmet medical needs in neurological disorders.