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Director, Process Modelling

CSL Behring

This is a Contract position in Upper Merion Township, PA posted July 14, 2020.

About CSL With operations in 35 nations and 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.

Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus.

CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

CSL Behring operates CSL Plasma , one of the world’s largest collectors of human plasma, which is used to create CSL’s therapies.

Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team Job Description The Global Owner of Process Modelling role is accountable for developing a global center of excellence for modelling and scale-up of processes and systems based on CSL Behring engineering standards, current regulations, and industry standards and practices for biopharmaceutical manufacturing.

This leader will be responsible for developing capabilities for process modelling and simulations enabling optimization of biopharmaceutical production at multiple sites across a global network.

This role will have a wide focus requiring an understanding of how to integrate the activities of numerous areas of technical, operational, and business expertise and align them toward accomplishing common goals.

1 Develop and maintain a global center of excellence with best practices, strategies and framework enabling modelling, simulation and scale-up of processes and systems (within the scope of technology transfer and validation) based on current regulations, industry standards and industry practices for biopharmaceutical products.

Through collaboration with R&D and Process Engineering, apply a science-based approach to process modelling with an understanding of how the systems and equipment enable and control the process.

Enable data-based evaluation of options to implement process robustness improvements, innovative technologies and new processes/systems at commercial facilities Apply Lean Six Sigma approaches, in alignment with the End-2-End Operational Excellence framework, to drive efficiency biopharmaceutical processes by establishing practices that enable process and system optimization.

Lead the staff who will conduct process scaling and optimization simulations based on current process and facility knowledge to support supply chain network strategy decisions and subsequent technology transfers.

Identify and evaluate innovative technologies to enable digital transformation of CSL Behring systems and processes in parallel to capital projects and tech transfers.

Establish a recipe approach (e.g., ISA-88) to process definition to enable standardization, process platforms and right-first-time technology transfers and validations.

Collaborate with partners such as IT, Enterprise Systems, Data Analytics, and Automation to evaluate and implement technologies and procedures to enable a globally harmonized approach to data collection, modelling, simulations, system qualification and optimization of biopharmaceutical production that will enable successful technology transfer and validation.

Establish process performance metrics and provide progress reports to senior management.

Enable continuous process verification 2 Management: Directly oversee staff at multiple international sites.

Responsible for development of 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 direct reports Coach, counsel, and appraise performance of personnel.

Develop staff competencies & capabilities to enable sustained success and career development Promotes high employee engagement and a positive work environment.

Responsible for organizational design, resource requirements and staffing decisions.

Recruit, retain, train and develop the team.

Education: Undergraduate degree in Engineering or other related technical field.

Graduate degree preferred Related Experience: 10 years working in process modelling and simulation with 5 years of experience in biopharmaceutical facilities and systems.

Demonstrated experience in managing a multi-layered department across multiple international locations.

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.

Experience with modern simulation and modeling tools and solutions Special Training: Lean Six Sigma training/certification is a plus.

Competencies: Customer Orientation (Internal/External): Creates companywide strategies to stay ahead of industry-related changes.

Drives alignment across the enterprise in order to serve customer needs.

Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.

Enterprise Results and Value Orientation: Looks for outcomes that maximize the benefits for the enterprise, not just their department or function.

Pursues value realization for the enterprise even if their function does not benefit.

Collaboration and Influencing: Champions a culture of inclusiveness and teamwork.

Collaborates effectively with others and influences all stakeholders towards enterprise outcomes.

Embraces conversations needed to deliver enterprise value.

Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

Problem Solving, Creativity and innovation management: Uses rigorous logic and methods to solve difficult problems with effective solutions, can see hidden problems, is excellent at honest analysis.

Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

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