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Project Manager, Drug Product Development

1 month ago

Charleston, West Virginia, United States Alcami Corporation Full time
Job Summary

The Project Manager plays a pivotal role in driving results in a dynamic environment by overseeing projects from inception to completion. This individual must possess a strong scientific and technical understanding of Alcami services, enabling effective interaction and communication with highly educated industry thought leaders. The Project Manager leads cross-functional project teams to deliver against contracted commitments and timelines, ensuring timely completion and compliance with cGMP and other relevant company training requirements.

Key Responsibilities
  • Establishes, leads, and manages project teams to deliver against contracted commitments and timelines for Alcami services.
  • Assesses the scope of services included in the contract and creates a detailed timeline outlining actions, deliverables, and risks.
  • Identifies and requests resources, including technical and scientific resources required to execute the project from functional areas.
  • Reviews the contract scope and project schedule with the project team to identify gaps, risks, and additional proposed services that may be required to successfully execute the project.
  • Communicates with Business Development on any required items that are out of scope and may require amendment to the contract.
  • Leads the project kick-off meeting with the customer, introducing the team and presenting the scope, timeline, risks, and proposed additional activities.
  • Leads project team activities and actions, monitoring progress against the established timelines and providing regular updates to internal stakeholders and customers.
  • Resolves conflict by providing proactive escalation of project or customer relationship issues to internal stakeholders and provides a proposed corrective course of action.
  • Maintains accurate timelines, monitors forecasted revenue, and tracks and manages GMP documentation through Master Control, the Company's validated electronic document management system.
  • Updates site files used to calculate and display project metrics such as Right First Time, On Time Delivery, and Schedule Adherence.
  • Demonstrates fiscal responsibility to monitor, forecast, and calculate the profitability of the assigned project(s).
  • Generates change orders and works closely with Business Development to generate new proposals for additional work associated with the project.
  • Serves as the main point of contact for the customer for all project-related activities and issues, including any questions or disputes related to invoices.
  • Partners with the Director of Project Management to implement improvements to the Project Management processes and systems.
Requirements
  • Bachelor's degree in a scientific discipline required; Master's degree preferred.
  • 3 years of related pharmaceutical or biotech experience required.
  • 2 years of experience leading multi-disciplinary project teams in a service business required.
  • CMO or CDMO experience preferred.
  • Prior experience in a customer-facing role required.
  • Formal project management training or certification preferred.
About Us

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve.