Cyclotron Engineering Lead / Project Manager at SOFIE

Cyclotron Engineering Lead / Project Manager

Title | TSG Cyclotron Engineering Lead

Department | Technical Services

Reports To | VP TSG

Overview

This position will develop and oversee the implementation of capital projects and major equipment purchases across the SOFIE network. Responsibilities include interfacing cross-functionally with both internal customers and external vendors and suppliers to ensure projects are delivered on time and within budget. This position will utilize breadth of knowledge across facilities, engineering and radiopharm manufacturing to ensure regulatory compliance and effective project execution.  

Essential Duties and Responsibilities

• Collaborate closely with internal stakeholders (PMI team, facilities, manufacturing, production) to ensure alignment of resources, scope control and seamless execution
• POC for external vendors. Ensure timely execution, dependencies managed effectively, lead / lag times are considered as part of program, RO’s submitted timely, etc..
• Responsible for coordinating and managing all resources, including materials, labor, and equipment purchases.
• Provide on-site leadership, direction, and coordination cross functional disciplines to drive project completion, on time and on budget
• Overseeing the work and coordination of subcontractors to ensure quality and timely completion of tasks.
• Prepare project documentation, including Ghant charts, URSs and SOPs
• Develop and manage project timelines with a clear understanding of dependencies and critical path. Monitor project progress and recommend/make adjustments as needed to reach key milestones.
• Facilitate project meetings for key stake holders, prepare minutes for select meetings, and track action items and decisions.
• Actively and effectively manage the delivery of project goals in accordance with the program strategy (i.e., management of integration, scope, timeline, cost, quality, resources, communications, and risks).
• Partner with the team to proactively identify and document risks and issues within the project; work with the team to devise and implement effective risk management strategies.
• Provide project updates on a consistent basis to various stakeholders, including the leadership team, about project status, risks/issues, budget and required adjustments.
• Facilitate project meetings, prepare minutes for select meetings, and track action items and decisions.
• Measure project performance to identify areas for improvement.
• Contribute to the best practices of project/program management to support the evolution of operations. (production, quality, finance).

Qualifications

• Strong radiopharmaceutical project management skills and proven experience in having managed capital projects with emphasis on site utilities and equipment (cyclotrons, Hot cells, etc) in PET manufacturing facility.
• 10+ years of project management in radio-pharm manufacturing with a background in facilities maintenance. Cyclotron and Hot cell installation are mandatory.
• Have working knowledge of CMMS/EAM functionality.
• Be able to work with and influence stakeholders.
• Experience in GMP-regulated environment (Life Science, Pharma, Med Device, etc.)
• Understanding of detailed theory of operation for accelerator systems a plus.
• Ability to read and interpret mechanical and electrical drawings, architectural, MEP and P&ID Drawings.
• Experience working in hazardous environments, preferably high power and radiological.
• Ability to climb ladder and stairs, work in protective clothing with respirators, operate in confined spaces (i.e., inside, or underneath the cyclotron) and lift a minimum of 50 lbs. required.
• Strong Understanding of GMP Facility Iso Standards, HVAC & Building Controls. Knowledge of critical utility systems such as compressed air/gases, HVAC .
• Occupational exposure to ionizing radiation required.
• Proficient with construction terminology and legal content of construction contracts, documents and logistics
• Work with high voltage equipment required.
• Detailed oriented, accountable, able to work in a team environment with minimum supervision required.
• Travel up to 75%, project dependent.