Director, Process & Analytical Lifecycle Management Site Lead

  • Vollzeit
  • Marburg

Webseite CSL Behring GmbH

For our Global Engineering Team we are looking for a

Director, Process & Analytical Lifecycle Management Site Lead (f/m/d) – R-169599

(fulltime/ permanent)


Position Purpose:

The Process & Analytical Lifecycle Management (PALM) Site lead role is accountable for execution of all verification/commissioning, qualification and validation deliverables within the scope of the global Process & Analytical Lifecycle Management function.  This role leads managers with site teams comprised of engineers, scientists, and project managers.  Supports and understands all end-to-end functions, networks and needs from a manufacturing site perspective and coordinates global function integration on site.


Main Responsibilities and Accountabilities:

  • As a representative of the PALM function, this role will be accountable for successful implementation of global best practices, policies, and framework developed and by the Global Engineering organization.
  • As a representative of Marburg site, accountable to participate with other site leaders and centers of excellence supporting global initiatives toward harmonization and knowledge management efforts
  • Drive development of site-specific procedures that enable the implementation of global policies and standards.
  • Ensure site projects are properly resourced and controlled for successful completion on time, within budget, and in alignment with global requirements and site needs. Lead and direct project management staff responsible for integrated planning and timelines across multiple projects requiring tech transfer, verification/commissioning, qualification and validation activities.  This includes management and negotiation of cross-functional dependencies and interactions.
  • Monitor and summarize metrics, risks and issues for all PALM projects on site.
  • Prepare regular reports for site and global management and appropriate governance committees.  Ensure resolution of issues and mitigation of PALM risks and escalate as necessary.
  • Develop a high-performing team of skilled PALM practitioners who will execute projects in alignment with global network strategies and according to policies and practices developed by global centers of excellence.
  • Support evaluation of site capabilities for evaluation of the CSL global network for process and method transfer siting decisions.
  • Represent PALM function for site inspection readiness, execution, and responses.  Coordinate the support of PALM global and site-based SMEs as needed.
  • Directly oversee PALM managers with oversight of staff and contract resources. Responsible for development of PALM managers and staff, including motivating in a manner that promotes the achievement of CSL’s business goals and objectives.
  • Establish performance goals and strategic/operational objectives for department
  • Develop staff competencies & capabilities to enable sustained success and career development
  • Responsible for organizational design, budget resource requirements and staffing decisions. Recruit, retain, train and develop the team.

Position Qualifications and Experience Requirements: 

  • Graduate degree in Engineering or other related technical field.
  • 15+ years working in commercialization of biopharmaceutical products and processes.
  • Demonstrated experience in managing a multi-layered department across multiple technical specialties.
  • Strong communication, negotiation and conflict management skills to influence technical experts and stakeholders at all levels in the organization
  • Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates.
  • Must have a strong understanding of biopharmaceutical operations and relevant GMP regulations and regulatory guidance.
  • Lean and Six-sigma training are a plus.

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