Company Background
The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.
Position Overview – Houston Based
Reporting to the Manager, Sterility Assurance, the QC Analyst in Quality Control, Environmental Monitoring, will be responsible for execution of tasks related to environmental monitoring, aseptic processing and microbial control at Neurogene’s Houston GMP manufacturing facility. Testing associated with intermediate and finished product stability studies will also be the responsibility of the QC Analyst. This individual will support the effort in working with QC Operations, Manufacturing and Validation personnel to collect baseline data and set acceptance criteria for routine testing as well as any validation activities related to environmental monitoring, bioburden, and endotoxin testing. This role will also be responsible for maintaining the qualification status of operator training, aseptic filling processes and integrity testing. The QC Analyst in QC EM will support sampling and testing of raw materials and will be responsible for supporting the monitoring of the state of control of the clean room environment, processes and personnel to ensure uninterrupted supply of Neurogene’s clinical products.
Accountabilities and Responsibilities
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Establish environmental sampling maps for defined clean room areas
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Performed compressed gas testing in clean rooms
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Revise SOPs, material specifications, and work instructions as determined by Sterility Assurance Manager
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Participate in daily, weekly and monthly monitoring of the cleanroom environment
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Obtain training on operation of the MODA Environmental Monitoring (EM) data collection system
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Performance of EM validation activities as required.
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EM sampling of GMP Cleanroom suite during at-rest and in-operation activities.
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Scheduling of Water system and clean steam sampling and testing
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Prepare trending and technical reports
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Establish alert and action limits based on statistical analysis of environmental data at rest and in operation
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Investigate and recommend corrective actions for environmental excursions
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Obtain training in microbiological techniques and procedures
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Obtain training to qualify Manufacturing staff in aseptic techniques
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Maintain aseptic process validation and operator qualification programs
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Support Manufacturing during aseptic processing simulation activities.
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Support batch and raw material testing including growth promotion, bioburden, and endotoxin testing.
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Other activities as defined by the Sterility Assurance Manager and Senior Director of Quality Control
Essential Job Details
Work Schedule - Full time, day shift
Travel - N/A
Safety - Knowledgeable and complies with all pertinent safety policies, rules and regulations.
Quality Responsibility - Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Scope - Works on problems of moderate scope. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action. Interprets results in comparison to established specifications.
Minimum Requirements
Education • BA or BS degree in Biology, Biotechnology or related science field.
Experience • Minimum 2 Years of Quality Control Experience
- Previous experience in a Quality Control role in the gene therapy field is preferred but not required
Knowledge, Skills & Attributes
- Knowledge of Microsoft Office products
- Working knowledge of GMP/GLP operations
- Understanding of typical QC instrumentation
- Experience with environmental monitoring, raw material testing, etc.
- Must be able to perform final fill inspections
- Time management skills required for organization of daily test schedules
- Record keeping skills required to ensure accuracy and authenticity of data
- Organizational skills required for maintaining proper sample management
- Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
- Ability to track and measure performance against defined metrics.
- Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
- Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
- Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
Work Environment
- Majority of work is done in a lab environment; and work may involve common hazards found in a lab environment. In some areas, gowning may be required.
This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Neurogene’s business, this description is subject to change and may be modified at any time, whether formally or informally.
