Project Manager, CMC

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.

About the Role - Reporting to the Director, Program Management, the Associate Director, Program Management, CMC, is accountable to the program management function for managing CMC activities to support Neurogene’s programs in the clinic. This individual will create overviews of the required work packages, align timelines of the cross-functional activities, connect these to the overall program development timelines and work with our Finance Team to ensure we can appropriately allocate resources and stay on track for our programs. Furthermore, the CMC Program Manager will be a key contributor in optimization of cross-functional processes and connecting different functions in the CMC organization to align all the program deliverables and timelines.

Responsibilities

• Drive CMC operation workstreams in support of Neurogene’s clinical programs, managing internal project teams and external partners.
• Make inventory of all work/experiments required, build the program plan and monitor progress, identifying opportunities and escalating in a timely manner to Leadership when objectives may not be met.
• Ensure close collaboration with the responsible CMC functions, including additional cross functional teams as required, to optimally execute the CMC activities and facilitate decision-making.
• Facilitate internal and external team communication, including scheduling and chairing meetings, sending out agendas, writing and distributing meeting minutes, tracking action items, and reporting on goals.
• Manage cross-functional dependencies and align with internal and external functions for integrated program planning.
• Actively contribute, in collaboration with the Portfolio & Program Management Function, to building program management tools and capabilities, as well as ultimately feed these programs into the corporate dashboard.

Qualifications - Bachelor’s degree or higher with strong scientific background and knowledge of viral vector gene therapy or biologics manufacturing processes

Required Skills

• 6-8 years of experience in pharmaceutical or biotech, with 3-5 in Program Management in a GMP setting
• Gene therapy and/or biologics experience preferred
• Experience managing various aspects of GMP manufacturing campaigns, including process development, technology transfer, assay development and qualification, QC testing and batch release
• Experience with late-stage clinical programs will be an advantage

Preferred Skills

• PMP or equivalent will be an advantage
• In-depth understanding of project management principles
• Knowledge of cGMP regulations
• Good knowledge of MS Office
• Advanced capability with enterprise planning software such as Smart Sheets is required
• Outstanding communication and matrix management skills
• Continuous strong focus on meeting or exceeding expectations 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.