What are the responsibilities and job description for the Director, Manufacturing Science and Technology - Gene Therapy - Viral Vector position at Neurogene Inc.?
Brief Description
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 - Gene Therapy Required - Viral Vectors
We are seeking a talented and motivated MSAT (Manufacturing Science and Technology) professional to join our dynamic team. As an MSAT professional, you will play a crucial role in the advancement and optimization of biotechnology processes, ensuring the safe and efficient production of life-changing medicines.
Requirements
Accountabilities and Responsibilities
Work Schedule
Day shift
Travel
<5%
Safety
Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
Quality Responsibility
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 issues of diverse scope where analysis of situation or data requires a review and evaluation of identifiable factors. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action.
Leadership Responsibility
1-2 direct reports and indirect matrix management
Minimum Requirements
Education
A majority of the work is done in a private office, warehouse or manufacturing environment. The manufacturing environment is a cleanroom where appropriate gowning is required to be worn. Work may involve high energy hazards, such as steam, high pressure gases, flammable materials, high temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases.
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 - Gene Therapy Required - Viral Vectors
We are seeking a talented and motivated MSAT (Manufacturing Science and Technology) professional to join our dynamic team. As an MSAT professional, you will play a crucial role in the advancement and optimization of biotechnology processes, ensuring the safe and efficient production of life-changing medicines.
Requirements
Accountabilities and Responsibilities
- Collaborate with cross-functional teams to support process transfers, process scale-up, process improvements, and troubleshooting activities
- Develop and execute experiments to evaluate and optimize manufacturing processes
- Develop strategies for process characterization and process validation as programs approach commercialization
- Conduct data gathering, data analysis and interpret results to drive manufacturing process improvements and maximize product consistency and quality
- Author, review, and revise technical documents, such as protocols, reports, and standard operating procedures (SOPs)
- Provide technical expertise to resolve deviations, investigations, and out-of-specification (OOS) events
- Support technology transfers by providing technical oversight, participating in product and process risk assessments, and ensuring compliance with regulatory guidelines
- Assist in the qualification and validation of new equipment and processes
- Stay current with industry trends and advances in biotechnology, sharing knowledge and suggesting innovative solutions
Work Schedule
Day shift
Travel
<5%
Safety
Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
Quality Responsibility
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 issues of diverse scope where analysis of situation or data requires a review and evaluation of identifiable factors. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action.
Leadership Responsibility
1-2 direct reports and indirect matrix management
Minimum Requirements
Education
- Bachelor's degree in scientific discipline (Biotechnology, Biochemistry, Biology, or related field)
- Minimum 10 years of relevant experience in MSAT or process development within the biotechnology industry with at least 4 years of gene therapy
- N/A
- Strong knowledge of cGMP regulations and experience working in a regulated environment (FDA, EMA, etc.)
- Proficient in statistical data analysis software (JMP, Minitab, etc.) and process modeling tools
- 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.
A majority of the work is done in a private office, warehouse or manufacturing environment. The manufacturing environment is a cleanroom where appropriate gowning is required to be worn. Work may involve high energy hazards, such as steam, high pressure gases, flammable materials, high temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases.