Project Manager External Manufacturing

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT.

Position: Project Manager External Manufacturing
Location: Indianapolis, IN
Duration: Long Term

Job Overview

We are seeking an experienced Project Manager External Manufacturing to manage pharmaceutical manufacturing projects, including technology transfer, PPQ, batch release, and supply chain coordination. The ideal candidate should have strong pharmaceutical manufacturing and project management experience with the ability to coordinate internal teams and external manufacturing partners.

Key Responsibilities

• Manage end-to-end external manufacturing projects, including technology transfer, PPQ, batch release, and supply chain activities.
• Coordinate external manufacturing project plans with internal Lilly teams (BRD, Central TSMS, GQL) and contract manufacturing (CM) operational plans.
• Develop detailed project plans, including critical paths, timelines, and risk registers.
• Manage capital delivery and commercialization-related projects.
• Coordinate activities related to Validation, Technology Transfer, CMC, GMP, Quality, and HSE.
• Work with cross-functional teams and external partners to ensure project progress.
• Track project timelines, identify risks, and communicate project updates.
• Coordinate stakeholders across different teams and organizations.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Science, Engineering, Project Management, or a related discipline.
• 8+ years of experience in pharmaceutical manufacturing operations, technology transfer, or project management.
• Experience in pharmaceutical manufacturing environments.
• Experience managing external manufacturing or contract manufacturing activities.
• Knowledge of technology transfer, PPQ, batch release, and supply chain coordination.
• Ability to develop detailed project plans, critical path schedules, and risk registers.
• Experience managing capital delivery or commercialization/technical agenda projects.
• Direct or indirect experience with Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE.
• Strong project management, communication, and cross-functional coordination skills.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.