Executive Director, CMC Program Management (Biology)

Role Summary

Executive Director to lead operations and program management for a diverse portfolio of biology-based advanced therapies (AAV, CGT, protein biologics, viral vectors). Oversees cross-functional execution from early development through commercialization, ensuring timely supply, regulatory readiness, and strategic coordination across all technical and operational interfaces.

Responsibilities

• Lead a team of 6–10 program managers executing 20–30 biologics and CGT programs.
• Drive timeline acceleration and optimization, balancing priorities across internal and external manufacturing capacity, regulatory milestones, and resource constraints.
• Work closely with clinical, development and manufacturing teams to proactively identify and resolve development and supply bottlenecks impacting clinical, regulatory or commercial deliverables.
• Oversee clinical and commercial launch supply readiness through coordination with internal teams and external manufacturing group.
• Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages.
• Collaborate with Finance to inform investment needs and help secure program budgets in a timely manner.
• Provide program management leadership for tech transfers, manufacturing readiness, and process scale-up.
• Support post-commercial initiatives—label extensions, process optimization, and global expansion projects.
• Implement governance systems, KPIs, and escalation processes that ensure proactive risk management and portfolio control.

Qualifications

• Required: Bachelor's degree with 18+ years of experience in biologics or cell & gene therapy operations with a proven record advancing products through clinical and commercial stages, or an equivalent combination of education and experience.
• Preferred: PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences.
• Preferred: Deep understanding of vector biology, cell culture, purification, and analytical control strategies.
• Preferred: Demonstrated expertise in program management, regulatory coordination, and cross-functional execution under complex operational constraints.
• Preferred: Strong communicator who effectively bridges science, manufacturing, and business priorities.

Skills

• Vector biology, cell culture, purification, and analytical control strategies
• Program management, regulatory coordination, and cross-functional execution
• Strategic communication across science, manufacturing, and business stakeholders

Education

• Bachelor's degree required; 18+ years in biologics or cell & gene therapy operations (or equivalent)
• PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences preferred