What are the responsibilities and job description for the Manufacturing Associate - GMP - Houston position at Neurogene Inc.?
Brief Description
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 - Based In Houston.
The primary role of the Manufacturing Associate position will be production of gene therapy products at Neurogene’s GMP viral vector manufacturing facility. This position will help maintain an uninterrupted supply of materials for clinical trials. Level of the associate position will be determined based on relevant experiences.
Requirements
Accountabilities and Responsibilities
Work Schedule Day shift, some weekend work may be required
Travel <10%
Safety Is 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.
All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).
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.
Minimum Requirements
Education Associates Degree in Biology, Biotechnology, Biomanufacturing or related science field OR Bachelors in Biology, Biotechnology or related science field.
Experience Preferred but not required: Industrial experience in the area of biopharmaceutical production in a GMP environment.
Preferred but not required: Experience in operating with GMP Upstream and Downstream equipment and processes such as Bioreactors, Sterile Operations Under a Biosafety Cabinet, Chromatography Skids and Tangential Flow Filtration.
Licenses or Certifications N/A
Knowledge Understanding complex process equipment and instrumentation
Working knowledge of GMP
Skills Good aseptic technique
Able to perform procedures according to written guidelines
Able to develop or revise procedures when required
Able to perform repetitive tasks such as pipetting
Able to work within a manufacturing clean room (up to ISO 5 & Grade A) following training
Good basic computer skills
Interact effectively with staff members from multiple levels and departments
Ability to lift 50lbs, assisted.
Work Environment The majority of work is done in a manufacturing clean room environment. Work may involve high energy hazards, such as high-pressure gases, flammable materials, cryogenic operations, and chemical hazards such as strong acids and bases. In some areas, gowning (e.g. coveralls, face mask, shoe covers, hair and beard nets etc.) will be required.
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 - Based In Houston.
The primary role of the Manufacturing Associate position will be production of gene therapy products at Neurogene’s GMP viral vector manufacturing facility. This position will help maintain an uninterrupted supply of materials for clinical trials. Level of the associate position will be determined based on relevant experiences.
Requirements
Accountabilities and Responsibilities
- Operation of manual, semi-automated and automated equipment in support of routine production of pre-clinical and clinical biopharmaceuticals
- Large scale cell culture using single-use disposable bioreactor systems
- Viral vector purification with process scale chromatography equipment
- Preparation of buffer solutions
- Staging of equipment and raw materials in production suites
- Assist in other production related activities such as validation, data collection, inventory management and maintenance of process equipment
- Perform cleaning of facility and unit process equipment
- Write and review SOPs and change control documents for manufacturing work areas
- Ensure proper documentation is completed to meet quality systems requirements
- Participate in facility safety programs
- Resolving technical problems via internal teams and external sources such as vendor support.
- Additional responsibilities for advanced roles include:
- Authoring technical documentation such as summary reports.
- Leading project meetings
Work Schedule Day shift, some weekend work may be required
Travel <10%
Safety Is 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.
All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).
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.
Minimum Requirements
Education Associates Degree in Biology, Biotechnology, Biomanufacturing or related science field OR Bachelors in Biology, Biotechnology or related science field.
Experience Preferred but not required: Industrial experience in the area of biopharmaceutical production in a GMP environment.
Preferred but not required: Experience in operating with GMP Upstream and Downstream equipment and processes such as Bioreactors, Sterile Operations Under a Biosafety Cabinet, Chromatography Skids and Tangential Flow Filtration.
Licenses or Certifications N/A
Knowledge Understanding complex process equipment and instrumentation
Working knowledge of GMP
Skills Good aseptic technique
Able to perform procedures according to written guidelines
Able to develop or revise procedures when required
Able to perform repetitive tasks such as pipetting
Able to work within a manufacturing clean room (up to ISO 5 & Grade A) following training
Good basic computer skills
Interact effectively with staff members from multiple levels and departments
Ability to lift 50lbs, assisted.
Work Environment The majority of work is done in a manufacturing clean room environment. Work may involve high energy hazards, such as high-pressure gases, flammable materials, cryogenic operations, and chemical hazards such as strong acids and bases. In some areas, gowning (e.g. coveralls, face mask, shoe covers, hair and beard nets etc.) will be required.