GMP Manufacturing Programs Lead — Multi-Site CDMO Projects

BioSpace

Watertown (MA)

On-site

USD 180,000 - 264,000

Full time

8 days ago

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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Medical, dental, vision benefits
Flexible benefits
Well-being benefits

Job summary

Lilly seeks a GMP manufacturing project manager to lead cross-site, multi-CDMO programs, coordinating technology transfer, manufacturing readiness, materials, analytical testing, quality review, release, and delivery across internal sites and external partners.

The role demands senior program management in a cGMP environment, strong cross-functional collaboration with R&D, CMC, QA, Regulatory, and Supply Chain, and the ability to navigate complex dependencies with travel as needed.

Qualifications

  • Experience managing external vendors (CDMOs, CROs, or suppliers) in biopharmaceuticals.
  • Experience with sterile drug product manufacturing and fill-finish operations.
  • Demonstrated ability to build and manage project timelines for multi-vendor, cross-functional programs.
  • Proficiency in dashboards/reports using Smartsheet/Power BI/Tableau/Excel.

Responsibilities

  • Serve as GMP PM lead for drug product manufacturing across CDMOs and Lilly sites.
  • Develop and drive integrated project plans for tech transfer, manufacturing readiness, production, testing, release, and delivery.
  • Coordinate cross-functional planning among CMC, Manufacturing, Quality, Regulatory, Supply Chain, and program teams.
  • Establish milestones, dependencies, decision points, and owners across sites.
  • Lead manufacturing readiness reviews and ensure timely closure of actions.
  • Track GMP campaigns and communicate risks and impacts to teams and leadership.

Skills

Project management
Cross-functional leadership
Dashboards
Vendor management
Communication
Travel readiness
cGMP knowledge

Education

Bachelor’s degree in life sciences/chemistry/engineering/pharma
Master’s degree in life sciences/engineering/pharma
PhD in life sciences/engineering/pharma

Tools

Smartsheet
Power BI
Tableau
Excel

Job description

Lilly seeks a GMP manufacturing project manager to lead cross-site, multi-CDMO programs, coordinating technology transfer, manufacturing readiness, materials, analytical testing, quality review, release, and delivery across internal sites and external partners.

The role demands senior program management in a cGMP environment, strong cross-functional collaboration with R&D, CMC, QA, Regulatory, and Supply Chain, and the ability to navigate complex dependencies with travel as needed.

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