Lonza · 12 hours ago

Director, Project Initiation Lead- Remote U.S.

Portsmouth, NH

Full-time

Remote

Director/Executive

10+ years exp

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BiotechnologyLife Science

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Responsibilities

Ensure the project teams are resourced and set up to deliver the Global Engineering Front end initiation process.

Maintain control of project costs, scope, deliverables and schedule. Address escalations and implement appropriate mitigations for risks affecting the project delivery

Screen incoming business ideas/request, at ideation stage and develop an appropriate project execution strategy

Set project budgets, schedule baselines and appropriate project controls strategy, including management of scope changes for successful delivery of the project objectives

Provide leadership as part of Global Engineering Front end core team and manage the interfaces with Project Sponsor, Lonza stakeholders, Global cross functional teams & Customers

Oversee several Lonza and 3rd party contractor discipline leads

Qualification

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Engineering DegreeBiotechnology ProcessesProject ManagementPharmaceutical Industry StandardsProcess Modelling SystemsFDA RegulationsMS ProjectMS ExcelMS PowerPointMS Office

Required

Degree in Engineering (process, pharmaceutical, biochemical engineering or equivalent) or long time and in-depth project management in multiple international CAPEX projects

10+ years engineering experience or project management on Large Capital Projects (200MM) in chemical, biochemical, pharmaceutical industries, GMP facility with experience and expertise in the field of site/facility/process and utility functionality, setup and layout, knowledge of current technology in the field of building, building technology, Drug Substance processes, automation and utility technologies. Good project management skills

Fluent in English

Extensive experience in Biotechnology- / Pharma-Processes

Engineering Design, Commissioning & Qualification

Process Modelling systems (Superpro)

Pharmaceutical Industry standards, Quality requirements

Working knowledge of FDA Regulations including GAMP

Excellent problem solving and Project Management skills

Skilled expert of MS Project, MS Excel, MS PowerPoint, MS Office

Open to international business travel (approx 20%)