Senior GMP Program Director – Multi-CDMO Operations

Lilly; Watertown (MA); On-site; USD 180,000 - 264,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health benefits

Job summary

Lilly is seeking an experienced GMP manufacturing project manager to lead the planning and execution of non-viral drug product manufacturing with multiple external CDMOs and Lilly sites. You will drive technology transfer, manufacturing readiness, materials, analytics, quality, and delivery in a complex cGMP environment.

You will connect internal teams with manufacturing-site staff, identify dependencies and risks, facilitate critical decisions, and drive mitigation and recovery plans to ensure

Qualifications

• GMP project management experience in biopharma required.
• Experience managing external vendors (CDMOs/CROs).
• Sterile drug product manufacturing and fill-finish knowledge.
• Proven ability to manage multi-vendor cross-functional programs.
• Strong leadership and communication skills.

Responsibilities

• Lead GMP project management for drug product manufacturing across CDMOs and Lilly sites.
• Develop and maintain integrated project plans for tech transfer and manufacturing readiness.
• Coordinate planning among CMC, Manufacturing, Quality, Supply Chain, Regulatory, and programs.
• Establish milestones, dependencies, and accountable owners.
• Lead manufacturing readiness reviews on materials, methods, and release.
• Facilitate project-team and site meetings; document decisions and actions.
• Identify risks to GMP execution and material availability.
• Create mitigation and recovery plans with leads.
• Track GMP campaigns and communicate risks to teams.
• Support escalation and resolution while preserving accountability.
• Maintain portfolio visibility and prioritize activities across projects.
• Develop fit-for-purpose PM tools, governance, and reporting.
• Capture lessons learned for future batches and sites.
• Partner with business functions on budget/contract implications (no sourcing ownership).

Skills

GMP project management

Vendor management

Cross-functional leadership

Data dashboards

Education

Bachelor's/Master's/PhD in life sciences/chemistry/engineering/pharmaceutical sciences

Tools

Smartsheet

Power BI

Tableau

Excel advanced

Job description

Lilly is seeking an experienced GMP manufacturing project manager to lead the planning and execution of non-viral drug product manufacturing with multiple external CDMOs and Lilly sites. You will drive technology transfer, manufacturing readiness, materials, analytics, quality, and delivery in a complex cGMP environment.

You will connect internal teams with manufacturing-site staff, identify dependencies and risks, facilitate critical decisions, and drive mitigation and recovery plans to ensure