Neurogene exists to provide medicines to cure or substantially improve the lives of families and people living with neurological 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!
Reporting to the Vice President of Technical Operations, the Head of Process Development will manage all work activities in Neurogene’s process development (PD) department. S/he will also manage tech transfer of PD from Neurogene collaborators, as well as the design and workplan to establish PD labs to support Neurogene’s programs. This person will also be responsible for the development of all processes and analytical methods supporting Neurogene’s programs.
- Stay current and connected in the rapidly-growing field of cell and/or viral production and cell engineering; attend several outside meetings/conferences yearly, presenting whenever possible.
- Establish a platform process and enable continuous yield improvement and process improvement for all of Neurogene’s programs.
- Develop and establish suitable analytical methods for the analysis and characterization of Neurogene’s products.
- Set up and run a lab-based program for evaluation of new technologies and platforms for process development. Manage tech transfer process from academic institutions to GMP manufacturing as new programs come online.
- Interact with commercial development to evaluate new programs as needed. Effectively communicate direction and progress.
- Forecast and strive to meet budgetary targets. Participate in budget process and lab safety programs.
- Hire, train, and supervise direct reports, and encourage continuing education and development.
- Ph.D. in biochemistry, cell biology, or related field.
- At least 10 years of related experience and at least five years of supervisory experience.
- Working knowledge of global cGMPs related to all aspects of biologics manufacturing, including ICH Q7 and FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug product.
- Able to interpret and apply GMP and regulatory knowledge in routine and non-routine cases.
- Experience with all aspects of cell culture methods and techniques; experience with primary cells and large-scale culture helpful.
- 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.