Senior Director, CMC Lead

What you'll do:

• Develop and manage integrated CMC timelines for Ixo-vec. This includes timelines for activities to support Process Development, Analytical Development, Quality Assurance, Quality Control. Integrate CMC timelines with the Ivo-exe regulatory and project team timelines working the Ixo-vec Project Lead and the other functional PMs.
• Ensure all CMC team deliverables and activities are aligned with all teams, departments and facilitate communication to ensure clarity (including clear objectives and roles/accountabilities). at the different stages of development.
• Manage the CMC team scope, budgets, timelines, resources on Ixo-vec activities so the program remains within budget, on schedule, and within scope and identify and analyze project risks and help guide teams to develop appropriate mitigation strategies. Provide matrix leadership.
• Coordinate and facilitate CMC sub-team meetings (regularly scheduled and ad hoc) for Ixo-vec by providing meeting agendas, minutes, risk registers, and tracking decisions and action items.
• Develop and provide consistent project reporting to the CMC and Project Teams for Ixo-vec and Ixo-vec CMC status reporting to Senior Management.
• Partner with CMC Regulatory to provide support to secure source documents for CMC modules intended for on-time regulatory submissions.
• Mentor and support other functional PMs (including Regulatory, Process Development, and other functions, as needed, across the company)
• Foster a positive team culture of transparency, accountability, high cross-functional communication, and timely execution, with an emphasis on continuous evaluation, recognition, and process improvement.

About you:

• 12+ years of industry experience in the development of biologic products.
• Strong Project Management experience managing CMC development programs for gene therapy (preferred) or protein biologic programs.
• Experience managing multiple competing priorities and projects. Outstanding organizational skills.
• Strong leadership, influencing, interpersonal and communication skills. Energetic, flexible, collaborative and proactive team member and leader.
• Knowledge of process and product development, tech transfer, and supply. Support the product control strategy, including risk assessments, process characterization strategy, process validation (PPQ) strategy and plans. Experience with late-stage development and product licensure for a biologic product is a must.
• Experience working with external manufacturing and testing partners (CROs, CMOs, CDMOs)
• Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution.
• Experience with MS Office (e.g. Excel, PowerPoint), planning software (e.g. MS Project, Onepager)
• BS/MS/PhD in Biological Sciences or Engineering.