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Operational Readiness Lead

  1. North America, United States
Maryland
  1. Permanent
Competitive
  1. CAPEX Projects
33538
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Operational Readiness Lead - Pharma - Maryland - 12-Month Contract 

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a Operational Readiness Lead to help support operations at their Maryland facility.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!


Responsibilities:
  • Active management of cross functional implementation dependencies and identifying and escalating risks to the project leadership
  • Responsible for planning Biocentre design & delivery in the context of the overall project, focusing on infrastructure, fit-out, equipment, systems and certifications
  • Lead required internal and external stakeholder engagement, facilitating discussions and driving towards outcomes
  • Manage a detailed project plan on Biocentre build and delivery, across the HBST business team (incl. Biobank Network and Digital Integration), US R&D COO team, and Global Engineering
  • Run sessions to ensure all members of the project are bought into, and are intimately familiar with the project plan and priorities for any given period of time
  • Set up and run process to get latest information from team members for accurate and up to date reporting against the plan, escalating to project lead/manager where blockers/issues are identified
  • Maintain oversight of benefits realisation plan where metrics associated with the Biocentre are included and escalate any expected deviations
  • Ensure assumptions, design decisions and dependencies are documented and impacts understood by D&I and the Biobank network

Qualifications:
  • Broad / demonstrable experience of managing R&D engineering and/or technical projects of value $50m+ via formal project management methodologies and across multiple departments within a highly regulated environment
  • Proven track record of implementation of formal project controls methodologies
  • Bachelor’s of Science in an appropriate discipline
  • Extensive experience in Laboratory Operations within a pharmaceutical or clinical background
  • Knowledge of Study Management processes and local regulations
  • Evidence of excellent communication skills and building excellent relationships internally and externally
  • Advanced degree in a scientific discipline
  • Expert reputation within the business and industry
  • Knowledge of the latest technical and regulatory expectations

If this role is of interest to you, please apply now! 


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