CMC Ops & Program Lead — Cell Therapy

ElevateBio; Waltham (MA); Hybrid; USD 125,000 - 165,000; Full time

Job summary

ElevateBio in Waltham, MA is seeking a Manager, CMC Operations and Program Management to lead cross-functional activities across CMC, process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain within BaseCamp. The role supports internal portfolios and aligns program milestones with corporate goals in a GMP setting.

The position is hybrid with 2-3 days onsite a week, offering a salary range of $125,000 to $165,000 and opportunities to influence

Qualifications

• MS in a scientific or engineering discipline.
• 3+ years of relevant experience in the CMC environment; cell/gene therapy preferred.
• cGMP program management experience is required.
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred.
• Extensive experience leading product/process programs within a GMP setting.
• Program management skills including budgeting, metrics, and cross-functional coordination.
• Strong verbal and written skills; interpersonal, technical, and troubleshooting abilities.
• Excellent planning, organization, and multitasking skills.

Responsibilities

• Lead cross-functional activities between CMC groups and BaseCamp departments.
• Develop, maintain and track CMC project plans with milestones and budgets.
• Facilitate internal and partner meetings to drive cross-functional communication.
• Identify risks and bottlenecks; implement mitigation plans.
• Generate dashboards on milestones, updates and risks.
• Support Joint Leadership Meetings and standardization of processes.

Skills

Strong verbal and written skills

Interpersonal skills

Troubleshooting abilities

Planning and multitasking

Education

MS in a scientific or engineering discipline

Job description

ElevateBio in Waltham, MA is seeking a Manager, CMC Operations and Program Management to lead cross-functional activities across CMC, process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain within BaseCamp. The role supports internal portfolios and aligns program milestones with corporate goals in a GMP setting.

The position is hybrid with 2-3 days onsite a week, offering a salary range of $125,000 to $165,000 and opportunities to influence