ElevateBio

1 day ago

Manager, CMC Operations Program Management

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 18 hours agoStatus: Live

Job Summary

Lead cross-functional CMC program management activities across process development, analytical development, facilities/engineering, MSAT, manufacturing, and supply chain within ElevateBio BaseCamp programs. Build and maintain CMC project plans (Gantt, budget, resources), facilitate internal and partner meetings, track milestones, risks, and KPIs, and maintain risk/decision/change documentation. Support program alignment with corporate goals and prepare materials for joint leadership meetings.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Manager level

Key Responsibilities

•Lead cross-functional CMC program activities across process development, analytical development, facilities/engineering, MSAT, manufacturing, and supply chain.
•Build, maintain, and track CMC project plans (Gantt, budget, resources) and deliverables aligned to program objectives.
•Facilitate internal CMC team meetings and meetings with BaseCamp partners to drive communication and decisions.
•Proactively identify risks, gaps, and resource bottlenecks and develop mitigation plans.
•Maintain program documentation (risk registers, decision logs, change requests) and generate dashboards/KPIs; support joint leadership meeting content and invoicing with finance.

Pay and Benefits

Salary: USD 125,000 - 165,000

Key Requirements

•3+ years of relevant CMC experience in a cell/gene therapy 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 (preferred).
•Extensive experience leading product/process programs within a GMP setting.
•Strong planning, organization, multitasking, and verbal/written communication skills.

Experience:3+ yearsCell and gene therapyCMCGMP

Skills:CommunicationInterpersonal skillsTroubleshootingPlanningOrganization

Languages:English

Company Brief

ElevateBio

Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Cambridge, United States

Founded: 2017

Website LinkedIn

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ElevateBio

1 day ago

Manager, CMC Operations Program Management

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 18 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Manager level

Key Responsibilities

•Lead cross-functional CMC program activities across process development, analytical development, facilities/engineering, MSAT, manufacturing, and supply chain.
•Build, maintain, and track CMC project plans (Gantt, budget, resources) and deliverables aligned to program objectives.
•Facilitate internal CMC team meetings and meetings with BaseCamp partners to drive communication and decisions.
•Proactively identify risks, gaps, and resource bottlenecks and develop mitigation plans.
•Maintain program documentation (risk registers, decision logs, change requests) and generate dashboards/KPIs; support joint leadership meeting content and invoicing with finance.

Pay and Benefits

Salary: USD 125,000 - 165,000

Key Requirements

•3+ years of relevant CMC experience in a cell/gene therapy 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 (preferred).
•Extensive experience leading product/process programs within a GMP setting.
•Strong planning, organization, multitasking, and verbal/written communication skills.

Experience:3+ yearsCell and gene therapyCMCGMP

Skills:CommunicationInterpersonal skillsTroubleshootingPlanningOrganization

Languages:English

Company Brief

ElevateBio

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Cambridge, United States

Founded: 2017

Website LinkedIn