Insights

Initiating manufacturing operations in a newly built pharmaceutical facility is a demanding process for any organization. Here the technology transfer team is responsible for both ensuring that the facilities meet the design requirement as well as successfully transferring all products to the new site. Understanding the costs, benefits, and risks of multiple solutions requires complex modeling. A top-tier medical technology company and PMA Consultants have been collaborating in evaluating diverse strategies to expand global production capacity. A key component of the growth strategy involves the transfer of specific operations to a new facility, which requires identifying resource limitations, prioritization of needs initially and continuously throughout the dynamic project.

Planning objectives included the following:

  • Need to develop strategies to support business needs in new market
  • Detailed plan to balance limited resources and prioritize needs
  • Risk Management is key to the success of the project
  • Balance project objectives with operations and marketing objectives
  • Make Smart Business Decisions based on hard data
  • Establish key operation milestones

Wave Planning Steps:

  1. Identify Key Phases for product registration
  2. Develop timeline for products
  3. Group products in waves
  4. Understand driving factors between products
  5. Develop each wave timeline
  6. Understand relationships between waves

Leveraging NetPoint

The project team used NetPoint for phased schedule development. NetPoint made it easy to engage cross functional SME’s in detail planning, develop detailed (daily) schedule for current phase, identify relationships (hard/soft logic), and load resources to each activity for equipment and labor. With NetPoint it was easy to display a logic-based schedule so the project team could easily identify relationships between product phases, adjust logic as necessary, and monitor resources.

Schedule Risk Assessment

The project team used NetRisk to conduct schedule risk assessment to better factor uncertainty and define risk drivers and duration ranges.

Benefits

  • Evaluate impacts of variability in manufacturing and testing procedures
  • Understand compounded effect from product/wave prioritization and resource allocation, together with schedule uncertainty
    Visibility of Cruciality, Criticality, Priority Index and Sensitivity
  • Provide back-up data for decision making

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Project Team

Angel Arvelo, PMP, LEED AP – PMA Consultants

Angel has extensive experience delivering large complex projects for clients in multiple industries. His experience includes work with oil and gas, pharmaceutical/GMP, life science, alternative energy, power generation & utilities, civil infrastructure, as well as commercial development projects.

Blake Cuneo – PMA Consultants

Blake’s experience has focused on the pharmaceutical, residential, and civil infrastructure industries. Building on this experience, Blake has developed a specialization in scheduling and consulting, project and construction management, and overall project controls.

Tim Stoll – Medical Technology Company

Tim is an accomplished real estate and construction management professional with over 5 million SF and $2 billion of development and construction work successfully completed. He is an expert communicator with strong leadership skills, able to distill complex technical issues into clear strategies and lead successful execution of real estate endeavors.

Jennifer Cipollini – Medical Technology Company

Jennifer has long-standing experience leading project managers in the transfer of new pharmaceutical products from R&D into GMP manufacturing locations. Last year, she embarked on a new role, driving global transfer of pharmaceutical products to a new manufacturing site overseas.

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