Cell Therapy CMC Ops & Program Lead

ElevateBio; United States; On-site; USD 125,000 - 165,000; Full time

Benefits offered by this job

Health benefits

Competitive salary

Job summary

ElevateBio is seeking a Manager of CMC Operations and Program Management to lead cross-functional activities across CMC groups and BaseCamp partners. You will coordinate process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain to align with program goals and corporate timelines.

You will build internal and external relationships, develop detailed project plans, manage risks, and drive effective communication across teams.

Qualifications

• BS in a scientific or engineering discipline required.
• 3+ years of relevant experience in the CMC environment; cell/gene therapy preferred.
• cGMP program management experience required.
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products are preferred.

Responsibilities

• Build and maintain relationships with SMEs at Base Camp and partner organizations to ensure program goals.
• Develop and track CMC project plans with SMEs to milestones and deliverables.
• Facilitate cross-functional meetings to drive communication and timely decision-making.
• Identify risks and bottlenecks; develop mitigation plans with impacted teams.
• Generate dashboards showing milestones, updates, risks, and challenges.
• Maintain risk registers, decision logs, and change requests.
• Prepare content for Joint Leadership Meetings.
• Standardize processes and communications to build department efficiencies.
• Contribute to management and review of BaseCamp KPIs.
• Hold weekly 1:1s with BaseCamp partner counterparts.
• Collaborate with finance for invoicing.

Skills

Program management

Cross-functional collaboration

GMP knowledge

Regulatory understanding

Communication

Planning and multitasking

Education

BS in scientific or engineering discipline

Job description

ElevateBio is seeking a Manager of CMC Operations and Program Management to lead cross-functional activities across CMC groups and BaseCamp partners. You will coordinate process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain to align with program goals and corporate timelines.

You will build internal and external relationships, develop detailed project plans, manage risks, and drive effective communication across teams.