Value Stream Lead, Fractionation Operations

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 Reporting to the Kankakee Manufacturing & Site Head will lead and direct the Fractionation Value Stream at the Kankakee Site and all activities to achieve safety, quality, reliability and cost objectives within the Value Stream.

This role has full accountability for the Fractionation Value Stream ensuring that high quality products are delivered on schedule and within budget.

This individual will lead through a high degree of cross functional collaboration and communication within the Value Stream, performing activities such as creating a Value Stream plan with goals/tactics, leading the cross functional team, leading several Value Streams based people processes, and enabling a high degree of employee engagement for the Value Stream.

The role is a member of the Site Leadership Team providing leadership, supporting key site-wide goals and initiatives, mentoring, and guidance to achieve overall site business and activities.

The role is a member of the Site Leadership Team providing leadership, supporting key site-wide goals and initiatives, mentoring, and guidance to achieve overall site business and activities.

The role will have several manufacturing direct reports as well as overall accountability for the achievement of the value stream results (through put, quality, safety, cost), establishing operational plans with a short
– to mid-term impact.

Key Responsibilities: Provides leadership and direction as well as develops employees to meet both their career goals and the organizational targets Lead the Fractionation Value Steam to deliver against plan and achieve target for quality, safety, reliability and cost Works within the CSL Operating Model to marshal the appropriate resources to drive the highest level of collaboration, effectiveness and efficiency of the value stream Develops and implements strategies, policies and procedures to improve performance, product quality and efficiency in all manufacturing processes within the value stream Ensure the implementation and ongoing operation of the value stream.

This includes clear definition of responsibilities and accountabilities for all manufacturing responsibilities within the value stream.

Appraise Value Stream performance against objectives of quality, safety, reliability and cost; communicates progress at the site and global level Plans and oversees maintenance programs, inventory controls and validation activities.

Ensure all manufacturing activities for the value stream comply with global compliance regulations, relevant acts, legal demands and CSL’s Code of Conduct Ensure product and facility compliance with all relevant regulatory bodies in all target markets with a focus on regulatory compliance.

Ensure the value stream provides efficient, effective and compliant execution of quality responsibilities to assure that only materials and products that are safe and fit for purpose are released into the facility, transferred to other values streams, other sites or into the market.

Proactively manage internal and external relationships to deliver on goals Manufacture products to a quality standard that ensures drug safety, especially regarding the pharmaceutical quality of products, including the execution of all necessary measures in the case of complaints and possible recalls.

Ensure the development of suitable measures for the limitation of possible negative impacts.

Ensure optimal inspection readiness, including appropriate preparation to enable a positive execution of any and all regulatory inspections and other third
– party audits and the initiation of analysis of inspection results as well as corrective and preventative actions and ensuring that the responses to authorities are given in a timely manner and the commitments are consistent with operations at other CSL facilities.

Plan the optimal utilization of headcount (both permanent and temporary), equipment and material through effective production control techniques to achieve budget, product quality, compliance and timely supply objectives.

Plans, budgets and schedules facility modifications including estimates on equipment, labor, materials and other related costs Identify and implement continuous process, productivity, and cost improvements Develop and implement effective processes and systems to ensure CSL’s products meet operational, regulatory and business plan schedules.

Collaborates with other functions to drive improvement in operating effectiveness and efficiency, improving production processes, methods and implement new initiatives.

Drive a culture of risk-based continuous improvement across the business to drive development and operational excellence.

Collaborates across the CSL-network to ensure consistent operating methods Lead and drive strong business and financial competency in the management of manufacturing materials, COGs and the value stream P&L.

Direct the analysis of expenditure base to identify opportunities for cost reduction and productivity improvements.

Provide Value Stream Team Leadership Provide leadership and guidance to a site-based Value Stream team to effectively executive site goals and tactics.

Set objectives and provide clear direction for execution.

Responsible for staffing decisions including the acquisition of top talent; develops talent through the creation of development plans and executes on such plans Oversee the ongoing education and development of employees within the value stream Collaborates with colleagues within CSL’s manufacturing networks Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.

Education Bachelor’s Degree in Business/Business Management, Engineering, scientific, technology fields or equivalent in related subject Master’s Degree preferred, MBA desirable Experience Minimum of 12 years’ experience in a pharmaceutical operation with specific experience in 2 of these areas: QA, tech services/engineering, supply chain, manufacturing operations including familiarity with regulatory compliance.

8 10 years’ managerial experience in a pharmaceutical, biotechnology, or biological industry Strong managerial experience and track record in operational (plant) settings Demonstrated experience in financial management and understanding of business value drivers.

Regulatory awareness / capable to lead FDA and MHRA inspections cGMP Awareness Strong influencing skills / communication skills / team building skills Highly motivated / Results Driven / Robust and resilient / proven technical competency Hands-on Operational Excellence experience Competencies Managerial Courage: Does not hold back anything that needs to be said; provides current, direct, complete, and ‘actionable’ positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation quickly and directly; is not afraid to take negative action when necessary.

Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practice, trends and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.

Drive for Results/Execution: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.

Strategic Agility: Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.

Decision Quality: Makes good decision based upon a mixture analysis, wisdom experience, and judgment; most his /her solution and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

Innovation Management: Is good at bringing the creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; has a sense about managing the creative process of others; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace.

Developing Talent: Provides challenging and stretching tasks and assignments; holds frequent development discussions; is aware of each person’s career goals; constructs compelling development plans and executes them; pushes people to accept developmental moves; will take on those who need help and further development; cooperates with the developmental system in the organization; is a people builder.

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.

Managing Vision and Purpose: Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision sharable by everyone; can inspire and motivate entire units or organizations.

Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvement in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.

Organizing: Can marshal resources (people, funding, material, support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently.

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.