Pharma API Scale-Up Project Manager (GMP)

Process Alliance; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Process Alliance in Indianapolis, IN is seeking a Project Manager to lead pharmaceutical manufacturing scale-up and production of API for a specific molecule, partnering with cross-functional teams across operations, engineering, and quality.

You will manage end-to-end project execution, timelines, risks, and dependencies, ensuring GMP and regulatory alignment and a successful transition into manufacturing.

Qualifications

• 3+ years of project management experience in a pharmaceutical, biotech, or regulated manufacturing environment.
• Pharmaceutical project experience required.
• Working knowledge of GMP regulations and operating in a regulated environment.
• Strong understanding of project management principles, tools, and methodologies.

Responsibilities

• Lead end-to-end project management activities including planning, scheduling, execution, and delivery.
• Drive cross-functional coordination across operations, engineering, quality, and supply chain teams.
• Develop and manage project timelines, milestones, and deliverables to ensure on-time execution.
• Track risks, issues, and dependencies, and drive mitigation strategies.
• Facilitate project meetings, provide status updates, and ensure alignment across stakeholders.
• Support operational readiness efforts to ensure successful transition into manufacturing.

Skills

Project management

Communication

Stakeholder management

Regulatory understanding

Education

Bachelor's degree in Engineering, Life Sciences, Business, or related field

Job description

Process Alliance in Indianapolis, IN is seeking a Project Manager to lead pharmaceutical manufacturing scale-up and production of API for a specific molecule, partnering with cross-functional teams across operations, engineering, and quality.

You will manage end-to-end project execution, timelines, risks, and dependencies, ensuring GMP and regulatory alignment and a successful transition into manufacturing.