GMP-CMO Project Manager (Onsite, 18-Month)

System One Clinical & Science; Indianapolis (IN); On-site; USD 96,000 - 105,000; Full time

Job summary

System One Clinical & Science is seeking a Project Manager in Indianapolis, IN for an 18-month onsite contract. You will lead strategic and operational project efforts across API external manufacturing, coordinating quality, supply chain, engineering, regulatory, and finance with a focus on reliable commercial supply.

The role requires a bachelor’s in a technical field and at least 5 years in pharmaceutical/biopharmaceutical operations, with PMP or MS/MBA preferred.

Qualifications

• Bachelor's degree in engineering, a scientific field, or a related technical discipline and minimum of 5 years in pharmaceutical/biopharmaceutical operations.
• Advanced degree or professional certification (MS, MBA, Master’s in Project Management, PMP, or a commissioning/qualification/validation credential) preferred.

Responsibilities

• Facilitate and support CMO oversight and project delivery.
• Create and manage an integrated project plan articulating strategy for the CMO relationship and milestones.
• Coordinate cross-functional obligations between company and the CMO (quality oversight, supply coordination, deviation/CAPA, change-control, contracts, governance).
• Create and execute project plans; drive milestone delivery across the lifecycle.
• Develop team communication plans; inform stakeholders and leadership of decisions, risks and results.
• Monitor and prioritize project and supply risks; propose mitigations and contingencies.

Education

Bachelor's degree in engineering, a scientific field, or a related technical discipline

Advanced degree or professional certification (MS, MBA, Master’s in Project Management, PMP)

Tools

MS Project

Primavera P6

Smartsheet

Job description

System One Clinical & Science is seeking a Project Manager in Indianapolis, IN for an 18-month onsite contract. You will lead strategic and operational project efforts across API external manufacturing, coordinating quality, supply chain, engineering, regulatory, and finance with a focus on reliable commercial supply.

The role requires a bachelor’s in a technical field and at least 5 years in pharmaceutical/biopharmaceutical operations, with PMP or MS/MBA preferred.