Director, Manufacturing Science and Technology - Gene Therapy - Viral Vector

Brief Description

Neurogene's mission is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. The company is developing novel approaches to address limitations of conventional gene therapy in central nervous system disorders, including its proprietary EXACT transgene regulation platform. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas, where CGMP production of NGN-401 was conducted and will support pivotal clinical development activities.

Position Overview

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. Gene Therapy Required - Viral Vectors

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

Essential Details

• 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

Requirements

Education: Bachelor's degree in scientific discipline (Biotechnology, Biochemistry, Biology, or related field)

Experience: Minimum 10 years of relevant experience in MSAT or process development within the biotechnology industry with at least 4 years of gene therapy

Knowledge & Skills

• 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
• 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

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.