Manufacturing Production Head - MFG 19

Reporting to the Site Head. Responsible for all aspects of the manufacturing strategy design scale-up and sustaining the role will ensure the alignment of all Manufacturing functional areas including Upstream & Downstream processing Manufacturing Technology Maintenance Operational Readiness. Working closely with key internal stakeholders in Wuppertal and China the role has responsibility for ensuring the succesful scale-up of the manufacturing team to meet the start-up schedule.

Furthermore the role will be responsible for providing the necessary leadership across all site manufacturing activities in order to achieve site KPIs when in sustaining. Developing key relationships with external stakeholders and customers will also be critical requirements of this position in order to ensure the achievement of the business goals and long term strategy.

Essential Duties and Responsibilities:

1. • Will play an integral role in the strategy and business planning processes ensuring cross functional collaboration and leadership execution. Lead the development and implementation of site production plans to achieve forecasted goals and strategic objectives. Provide direction to the Manufacturing team with regard to achieving customer service requirements within defined timelines.
   • The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site Manufacturing organization.
   • Develop the overall Manufacturing strategy aligned with the facilitys strategic business plans and global Manufacturing strategy.
   • In collaboration with the Wuppertal Site Head and relevant colleagues within the WuXi organization develop and implement the strategic objectives for the Manufacturing team.
   • During the construction phase and beyond provide leadership and direction for all site production activities

i.e. safety supply planning quality cost inventory and stock management resource allocation and re- prioritization of activities as needed.

1. • Manage the interface between Wuppertal site and WuXi corporate Manufacturing team ensuring that the objectives of the Wuppertal sites team are aligned and delivered in accordance with the wider corporate objectives.
   • As a CMC leader interacting with internal teams and external clients for manufacturing related discussions to meet project goals response to the urgent manufacturing event and provide solution for execution to ensure delivery on time.

1. • Build and develop a high performing manufacturing management team including the attraction development and retention of talent.
   • Working with the Site Head and the HR function measure the Manufacturing teams performance against Key Performance Indicators.
   • Ensure the engagement of the team with Learning and Development initiatives and the performance management system for the site.
   • Develop a culture of continuous improvement recognition and constructive feedback for the team.
   • Identify and drive opportunities to achieve optimal and cost-effective productivity for the facility.
   • Provide direction to the Manufacturing team with regard to achieving customer service requirements within defined timelines.
   • Collaborate with other members of the leadership team to plan requirements for future capacity in line with strategic objectives cost efficiencies and delivery on new business opportunities.
   • Ensure appropriate processes and procedures are in place to enable the Manufacturing team to allocate resources and reprioritize production activities as needed.
   • Lead the implementation of cost improvement activities and the outsourcing of production steps as required.
   • Ensure the efficient and safe execution of site production plans and drive process robustness to reduce deviations in Manufacturing.
   • Develop overall strategies to manage supplier relationships and ensure raw material stock levels are in place and aligned with supply chain production planning and safety best practice procedures for the site.
   • Lead the Manufacturing team to ensure best value is achieved by minimizing the working capital within the supply and by driving lean cGMP manufacturing practices where possible without compromising quality and delivery.
   • Provide direction and expertise on complex compliance issues and ensure the Manufacturing team operates in accordance with relevant regulatory standards of best practice and Environmental Health & Safety.
   • Provide direction to the Manufacturing team to ensure expectations of quality delivery and cost are met by implementing appropriate processes to assess and manage all relevant risks.
   • Interface with Regulatory bodies as required representing the site to relevant authorities and regulatory inspectors in matters relating to production management quality safety and risk.
   • Ensure adherence to all safety and quality standards as the relate to Manufacturing i.e. continuous improvement regarding equipment and site safety.
   • Will be flexible to take on additional tasks and responsibilities at the discretion of the Site Head.
   • Will act as a role model for the Manufacturing function and also the wider organization in adherence to the WuXi corporate core values local site shared commitments/behaviours.
   • Further responsibilities of the Head of Manufacturing are defined in WX-SOP-01309 GMP responsibilities of Key Personnel and Departments
     
     
     Driving Strategy Vision & Business
2. • • Create and implement best practice manufacturing vision strategy processes and procedures to aid and improve business performance.
     • Develop and execute the sites strategic plan aligning with the companys overall goals and objectives.
     • Closely work with DS sites in the global Manufacturing Network and other global functions to ensure alignment and fit into the overall manufacturing network from a capacity and technology perspective.
     • Establish strategy and best practices for staff to ensure achievement of overall business objectives.
     • Collaborate closely with Business Development and Project Management Team as well as clients to understand their needs address challenges and ensure seamless project execution.
     • Establish and maintain strong relationships with key clients fostering long-term partnerships.

Quality Compliance and EHS

1. • • Uphold and impose the highest standards of quality and compliance ensuring that all manufacturing processes meet regulatory requirements (cGMP FDA EMA etc.).

1. • • Assures that the site is always inspection ready and acts as the site representative during inspections and audits.
     • Ensure that the function operates in accordance with any health safety and environmental policies and procedures to ensure the safety and wellbeing of staff and visitors.
     • Be a role model and enabler of our quality and safety culture.

Leadership and People Development

1. • • Provide visionary leadership fostering a culture of collaboration openness innovation and continuous improvement.
     • Setting high targets and coach mentor and develop direct reports and enable a high performing team to achieve set goals.
     • Act as a role model for the organisation in adherence to the WuXi corporate core values and local site shared commitments/behaviours.
     • Providing leadership and direction to create a culture of high performance and continuous improvement.
     • Ensure strong communication between teams under leadership to facilitate exchange of information and in order to implement changes and improvements.
     • Build a winning Team spirit collaborate closely with cross-functional teams including Quality Assurance Regulatory Affairs Supply Chain and R&D.

Person Specification

1. • • Excellent leadership and people management skills.
     • Strong conceptual thinking with strong presentation and representation skills.
     • Entrepreneurial mindset and strategic thinking with the ability to develop a vision and a roadmap to ensure excellence and further develop the drug substance sites organization and support the WuXi Biologics Germany strategy.
     • Excellent background in Mammalian Cell Culture based Biologics Operations and Industrialization Management.
     • Excellent understanding of corporate governance and compliance as well as organization design.
     • Proficiency in Lean Management and/or Operational Excellence desired.
     • Excellent command of the German and English language both written and spoken.

Experience

1. • • More than 10 years of experience in Biologicals Manufactuing and/or Operations Management with a well-rounded exposure to key cornerstones of the position.
     • Strong understanding of cGMPs successfully leading GMP compliant operations and interacting with regulatory agencies.
     • Site leadership experience in driving functional and cross function team excellence/business performance.
     • Proficient in planning and aligning as well as effectively and efficient communication.
     • Excellent understanding of the structure and execution of a complex start up of operation and CapEx project.
     • Excellent strategic/business planning budgeting and reporting experience.
     • Experience of working within a highly regulated multinational contract manufacturing environment is advantageous.
     • Experience in developing and conveying business case and strategic direction to senior level leaders.
     • Significant international/global best practice knowledge and experience desired.