CMC Lead Plasma


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Job Description

Objective/ Purpose:

  • Accountable for CMC Lifecycle Management of one or more plasma products
  • Represents the CMC team on the Global Manufacturing & Supply Product team
  • Leads a cross-functional CMC team to drive effective product Lifecycle Management

Accountabilities:

  • Responsible for CMC strategy to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product/process knowledge, capability & improvement, tech transfer, and process validation
  • Aligns with Global Manufacturing & Supply (GMS) Product team  on CMC Lifecycle Management strategy
  • Drives the link between CMC strategy on the GMS Product team and CMC execution on the CMC subteam
  • Ensure harmonization/ standardization between facilities and best practice sharing
  • Accountable to guarantee proper yield tracking and to provide accurate yield status and forecast
  • Drive Yield projects identification, scoping, prioritization, tracking, and reporting
  • Is the overall product/process expert for the product; provides bridges across expertise represented on the CMC team
  • Accountable for CMC sections of product dossiers
  • Provide Subject Matter Expertise of major process and methods investigations
  • Assess and provide feedback to cross-functional technical proposals and recommendations
  • Manage multiple workstreams and projects
  • Make sound and timely decisions based on project priorities.
  • Discern paths forward within ambiguous environments

Skills and Qualifications:

  • Higher Degree in engineering or life sciences
  • Experience operating globally in a matrix organization highly preferred
  • Profound and relevant technical experience, preferably within the plasma business
  • Experience defining the strategy and roadmap for complex, cross-functional CMC initiatives
  • Ideally deep and broad understanding of plasma manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen
  • Self-motivated with good interpersonal and communication skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools
  • Strategic enterprise thinking, finding innovative ways to serve patients to build reputation and trust
  • Creating an environment that inspires and enables people
  • Excellent command of the English language is essential, any other language is an asset

Locations

ITA - Rieti

BEL - Lessines, ITA - Pisa, Vienna, Austria

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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