GMP Operations Program Lead – Drug Product & CDMOs

Eli Lilly and Company

Watertown (MA)

On-site

USD 180,000 - 264,000

Full time

3 days ago

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Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being programs

Job summary

Eli Lilly and Company is seeking an experienced GMP manufacturing project manager to lead integrated planning and execution of non-viral drug product manufacturing activities across multiple external CDMOs and Lilly sites. You will align cross-functional teams, develop global project plans, and drive readiness, testing, and delivery to ensure reliable GMP material supply.

The role requires strong experience in cGMP programs, technology transfer, and coordinating across CMC, Manufacturing, QA,

Qualifications

Bachelor's, Master’s, or PhD in life sciences, chemistry, engineering, or pharmaceutical sciences with 17+ years (Bachelor's) / 15+ years (Master's) or 10+ years (PhD) in CMC and project management.
Experience managing external vendors (CDMOs, CROs, or suppliers) in biopharmaceuticals.
Experience with sterile drug product manufacturing and fill-finish operations.
Proficiency building dashboards and reports using Smartsheet, Power BI, Tableau, or equivalent and advanced Excel.
Strong leadership and cross-functional collaboration across R&D, CMC, QA, Regulatory, Supply Chain, and Finance.

Responsibilities

Serve as the GMP project management lead for drug product manufacturing activities conducted across multiple CDMOs and Lilly internal manufacturing sites.
Develop, maintain, and drive integrated project plans covering technology transfer, manufacturing readiness, production, analytical testing, quality review, release, and delivery.
Coordinate cross-functional planning among CMC, Manufacturing, Quality, Supply Chain, Regulatory, and program teams.
Establish clear milestones, dependencies, decision points, critical paths, and accountable owners across internal functions and manufacturing sites.
Lead manufacturing readiness reviews to confirm alignment on materials, methods, documentation, equipment, scheduling, testing, and release activities.
Facilitate recurring project-team and manufacturing-site meetings, document decisions and actions, and ensure timely closure of commitments.
Identify schedule, technical, quality, supply, and resource risks that could affect GMP execution or material availability.
Develop and drive mitigation, contingency, and recovery plans in partnership with the accountable technical and functional leads.
Coordinate cross-site dependencies where drug substance, drug product, testing, packaging release, or other activities occur at different locations.
Track the status of GMP campaigns and communicate emerging risks, decisions, and impacts to program teams and leadership.
Support escalation and resolution of issues affecting manufacturing execution while ensuring that technical and quality decisions remain with the accountable functions.
Maintain portfolio-level visibility across concurrent GMP manufacturing projects and help prioritize activities when timelines or resources conflict.
Establish fit-for-purpose project-management tools, templates, governance forums, and reporting practices for GMP manufacturing programs.
Capture lessons learned from manufacturing campaigns and incorporate them into plans for subsequent batches, sites, and programs.
Partner with the appropriate business functions on budget and contractual implications, without owning sourcing, contracting, or vendor onboarding.