Neurogene exists to provide medicines to cure or substantially improve the lives of families and people living with neurologic impairment. The day to day difficulty of caring for someone with a devastating neurologic disorder is a heavy burden for families, and we imagine a world where families no longer have to hear the message that their rare disease has no treatment. As an employee of Neurogene, you will be helping to make this dream a reality, and part of a culture of people in a start-up environment on a mission to make the world a better place!
Define the strategies for the development and characterization of Neurogene’s processes. Manage all work activities and timelines in the Process Development department. Manages the design and work plan to establish PD labs to support Neurogene’s programs.
Primary Accountabilities, Duties, and Responsibilities
- Stay current and connected in the rapidly-growing field of AAV production and attend several outside meetings/conferences yearly.
- Establish a platform process and enable continuous yield improvement and process improvement for all of Neurogene’s programs.
- Generate timelines and strategies for the development and characterization of the process for each of the programs at Neurogene.
- Generate development reports for the support of regulatory documents including pre-INDs, INDs, and other such meetings with regulatory bodies.
- Set up and run a lab-based program for the evaluation of new technologies and platforms for process development.
- Interact with business development to evaluate new programs as needed.
- Effectively communicate direction and progress.
- Forecast and strive to meet budgetary targets. Participate in the budget process and lab safety programs.
- Hire, train, and supervise direct reports, and encourage continuing education and development.
|Essential Job Functions|
|Safety||• Is knowledgeable and complies with all pertinent safety policies, rules, and regulations.
• Ensure that all team members comply with safety rules and regulations.
|Quality Responsibility||Ensures a culture is established and maintained in which Quality is understood to be the responsibility of all persons involved directly or indirectly in Neurogene’s activities. Adherence to cGMPs is required at all times during the manufacture of APIs, drug substance, and drug product.
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.).
|Job Scope||Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures schedules and performance requirements are met.|
|Leadership Responsibility||Responsible for leading and developing a group of professionals to support a fast-growing organization. Includes developing training matrices, creating developmental plans and succession plans, and creating a collaborative team structure. As part of site management team and various project teams, provides proactive and visible leadership to ensure the site/business unit delivers goals in a spirit of excellence.|
|Minimum Required Qualifications/Skills|
|Education||Ph.D. in Biochemistry, Cell Biology, or related field.|
|Experience||At least 10 years of AAV process development experience and at least 5 years of supervisory experience.|
|Licenses or Certifications|
|Knowledge||• Knowledge of AAV process development from an upstream and downstream perspective.
• Understand the molecular biology behind processes and is able to make adjustments to the system as needed to increase yield and/or quality of the product.
• Understands current technologies and approaches for the processing of AAV products and makes recommendations on suitable approaches.
• Understands current approaches in the gene therapy field and makes recommendations for the most suitable approach.
• Understands current yield constraints in the field and makes adjustments to the process to remove constraints as feasible.
|Skills||• Experience with all aspects of cell culture methods and techniques. Experience with primary cells and large-scale culture.
• Understanding of facility design requirements and operating principles for aseptic manufacturing.
• Understanding of gene therapy principles, industry practices, and standards with ability to apply these to GMP operations.
• Understanding of the principles of biologics manufacturing
• Demonstrated strong ability in problem solving, excellent interpersonal skills and the ability to prioritize multiple tasks. Must be able to act decisively.
• Uses a team-oriented approach to project management and problem resolution.
• Ability to work both independently and collaboratively in a team structure. Holds self and others accountable for achieving collective goals.
• Excellent verbal and written communication skills, including the ability to influence others and lead complex projects.
• Strong attention to detail with strong documentation and coordination practices.
• Demonstrated ability to multi-task and manage competing priorities.
• Demonstrated strength as a manager including mentoring and coaching of staff, establishing priorities, and delivering on projects within budget and on time.
|Working Conditions||A majority of the work is done in a stressful and demanding environment and consists mostly of office work.|