Company Background
At Neurogene, we focus on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome and NGN-101 for the treatment of CLN5 Batten disease. We are using our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. Our wholly owned and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. 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
Reporting to the Downstream Process Development Senior Scientist, the Scientist I plays a critical role in assisting with the planning, execution, and analysis of studies for Neurogene’s gene therapy pipeline and downstream process development work. This technical role in a rapidly growing start-up will support the Senior Scientist and broader Process Development Team, which is accountable for target process profile definition, process design and execution of all purification activities, including chromatography, UF/DF, centrifugation, product formulation, process scale-up and optimization activities, and all purification-related technical documentation. Other job functions may include laboratory maintenance, procurement of essential consumables, and cross-collaborative assistance with upstream process development, analytical development and manufacturing groups.

The successful candidate be part of a team that is designing, characterizing, and optimizing a robust, scalable, productive downstream process for the generation of therapeutic AAV products in the pipeline. In addition, the ideal candidate will have knowledge and/or experience of the regulatory guidelines surrounding cGMP manufacture, a general understanding of viral vector bioprocessing, and experience or understanding of the process characterization of AAV gene therapy products.

Accountabilities and Responsibilities

• Perform routine virus purification activities (buffer preparation, column packing, sampling, executing small scale and large scale purification runs)
• Independently maintains and manages equipment appropriately
• Independent execution in the preparation of buffers/reagents, TFF and AKTA set-up (bench-top to 50L scale), and sampling operations, monitoring of process performance, as well as cleaning and waste disposal to support process development operations.
• Support downstream technology strategies in various platforms including shakes flasks, 2L, 10L, and 50L from the development stage, tech transfer, engineering runs, and GMP manufacturing; Assist in and execute unit operations for development, toxicology, and GMP batches for viral vector production(s).
• Contributes to continuous improvement strategies by designing experiments and presentation of results to internal and external stakeholders; evaluation of new technologies and collaboration with vendors
• Ensuring adequate and appropriate inventory of materials and supplies, collaboration with supply chain, ordering materials
• Draft, edit, and/or review data capture forms, batch production records, standard operating procedures or standard work elements for process development equipment and/or unit operations.
• Maintain responsible laboratory protocols, data capture, lab notebooks, and/or files using GDP guidelines
• Collaborates with analytical development, quality control, and manufacturing on the planning of process development project timelines

Essential Details

Work Schedule

• Day shift

Travel

• Less than 5%

Safety & Quality

• Knowledgeable and complies with all company safety policies, rules, and regulations.

Minimum Requirements

Education

• BSc in a Biological Science/ Chemistry/ Chemical Engineering

Experience

• Minimum: BSc in a Biological Science/ Chemistry/ Chemical Engineering with 2-3 years of related experience, preferably in a biotech environment
• Experience with buffer preparation, routine sampling, preparation, execution, and analysis of buffers using standard measures such as pH, conductivity, osmolality.
• Strong understanding of chromatography and filtration-based purification methods.
• Experience in and understanding of basic upstream operations for virus/protein harvest from bioreactors, knowledge of aseptic technique, and associated general lab upkeep and cleaning procedures
• Experience with AKTA chromatography system
• Experience with Sartorius TFF system
• Experience with Repligen KrosFlo system
• Experience with Process Scale-up/Scale-down and Process Characterization
• AAV bioprocessing and development is a plus
• Experience in a GMP environment is a plus
• Must have a strong understanding of drafting and execution of Standard Operation Procedures and/or Standard Work Elements
• Working knowledge of global cGMPs related to all aspects of biologics manufacturing, including FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug substance/product is a plus

Skills

• Ability to work both independently and collaboratively in a team environment with the ability to adapt to changing priorities.
• Demonstrated problem solving, critical thinking, time management and interpersonal skills with the ability to prioritize multiple tasks.
• Must display effective oral and written communication
• Understanding of gene therapy principles, industry practices, and regulatory
  standards with ability to apply these to GMP analytics.
• Familiarity with tech transfer and scale-up using chromatography skids, UF/DF, and formulation development to high concentrations, and purification through pilot-scale.
• Attention to detail with strong GLP documentation practices.
• Proficient in basic MS Office (Word, Excel, PowerPoint)
• MFCS software experience is a plus
• Agreeable towork in a PD/GLP environment focusing on gene therapy for viral vector bioprocessing.
• Must be able to lift 25 lbs frequently and 50 lbs occasionally.

Working Environment

• Process development work may occasionally require time outside of normal
  business hours to plan, execute, and maintain experiments in order to meet the timelines

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.