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Oversee and manage operational aspects of ongoing improvement projects, acting as a liaison between project teams and line management. Support our programs by managing the review of the status of the project, budget, schedules and preparing status reports. Assess project issues and develop resolutions to meet productivity, quality and client satisfactions goals.
Job Responsibility:
Responsible for developing a clear structured technical transfer standard work plan and schedule
Ensure New Product Introduction (NPI) technical transfer team stays on agreed timeline
Facilitate site change controls associated with NPI projects and track NPI deliverables
Supports technical transfer project leader on implementing end-to-end communication plan to internal and external stakeholders
Provide report to senior management and stakeholders
Maintain NPI Standard Work Plan (SWP) templates
Works with individual stakeholder on issuing or updating role card for each well-defined task in the SWP
Facilitates project meeting with cross functional stakeholders and managing the meeting cascade in NPI value stream
Assists technical transfer project leader on updating and maintaining Zero Defect Transfer (ZDT) Project Plan in COSMO system
Tracks milestone attainment according to the ZDT project plan
Ensure analytical and process robustness assessments are scheduled and carried out
Facilitate the gate review with internal and external stakeholders for NPI projects
Responsible for working with NPI value stream on issuing or maintaining Process Understanding Plan (PUP) and facilitating product handover from NPI value stream to Process Centric Teams for commercial manufacturing campaigns
Requirements:
Bachelor's Degree
Preferably, 2-3 years experience in a relevant manufacturing environment
PMP certification is preferred
Demonstrated project management experience in pharmaceutical or similar regulated industry
Experience in improving quality, performance or processes in previous assignments/projects
Demonstrates expert knowledge and proficiency with general office procedures
Demonstrates resourcefulness, discretion, communication and independence to be effective
Has analytical skills and can interpret data
Excellent organizational skills with the ability to plan and execute projects
Strong communication and interpersonal skills, including listening, oral and written
Nice to have:
Knowledge/Experience supporting infused biologics
Experience developing project plans in a Good Manufacturing Practices {also cGMP} aseptic facility