Manufacturing Director

This position is the lead role for the 'MFG 7' Batch-Fed Single Use facility in the Manufacturing Department of the WuXi Biologics Manufacturing Organisation. The role is an integral part of the Manufacturing Department, responsible initially for the establishment of the MFG 7 facility during construction and commissioning and latterly the long-term leadership to ensure all customer requirements are delivered on time and in full. The MFG 7 Lead is responsible for building the MFG 7 Upstream and Downstream Teams in addition to the Manufacturing Technology technical group. The role is a critical leadership role on site requiring close collaboration with all functions on site.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Ireland. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

Department Description

As MFG 7 Lead (Director) you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Senior Manufacturing Director.

Your Responsibilities

• Key member of Manufacturing leadership team for WuXi Biologics Ireland. The incumbent will play an important role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
• 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 organisation.
• Support the development of the overall Manufacturing strategy aligned with the facility's strategic business plans and global Manufacturing strategy.
• Build the newly formed MFG 7 Organisation in Dundalk establishing clear team identity, roles, responsibilities, and hand-over with other functions.
• Supervisor to the MFG 7 Upstream Lead, MFG 7 Downstream Lead, MFG 7 Innoculation Lab and Cell Bank Lead and the MFG 7 Manufacturing Technology Lead.
• Provide oversight of the design, construction, and qualification of the MFG 7 facility in Dundalk.
• Serve as MFG 7 drug substance (inclusive of Upstream cell culture and Downstream purification) process subject matter expert, providing technical oversight to teams, and coaching to associate staff.
• Technical Point of Contact for customers in relation to MFG 7.
• Providing technical and commercial leadership of:
  • Oversight of day-to-day Upstream and Downstream manufacturing activities ensuring production timelines are met.
  • Collaboration with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
  • All MFG 7 product quality related investigations and corrective or preventative action.
  • Equipment, Facility and Documentation Changes within the facility.
  • Collaboration with MSAT, Process Development and Project Management groups on technical transfer and process validation.
  • New Product Implementation, including scale-up, through technology/process transfer to clinical and commercial manufacturing.
  • Providing technical input to manufacturing process validation plans, protocols, and reports.
  • Supporting all RFP business requests with required facility fits and technical information.
  • Ensuring continual improvement of all manufacturing documentation (SOP's MBR's, OJT's) to ensure they are current, accurate, and clear.
  • Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
  • Collaborate closely to assist the Senior Manufacturing Director in coordinating the work between the MFG 7 group and other functional groups to meet the production objectives and timelines.
  • Authoring and reviewing standard operating procedures and technical reports.
  • Support multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents recommendations relating to production management activities.
• Flexibility to take on additional tasks and responsibilities at the discretion of the Senior Manufacturing Director.
• Will act as a role model for the manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position, will have the following:

Education:

• BSc in a scientific or engineering discipline is required. Masters level qualifications is advantageous.

Knowledge/Experience

• More than 15 years' experience in a cGMP biological manufacturing environment with previous experience managing and/or leading functional and project teams.
• Experience across both Upstream and Downstream manufacturing activities.
• Greenfield or large site expansion experience is beneficial.
• Experience working with lean principals and implementing CI processes within a complex manufacturing operation.
• Must have a proven track record of extensive manufacturing knowledge and experience gained within the biopharmaceutical/pharmaceutical industry sector.
• Significant expertise in manufacturing processes and systems.
• Proven track record in delivering large scale manufacturing projects.
• Ideally, experienced in establishing a Manufacturing facility and large-scale design and construction project in a 'greenfield' context of similar size and scale.
• Technology transfer to commercial facility and trouble shooting skills are important for this position.
• Demonstrated success in scientific and technical proficiency, bioprocess implementation, cGMP operation, and teamwork are critical for this position.

Personal Skills:

• Excellent written and oral presentation skill, detail-oriented organizational skill, clear understanding of process control strategy and data management are also required for this position.
• Good decision making with strong judgment through collaboration and consideration of others point-of-view.
• Strong leadership competencies with demonstrated management skills
• Excellent people influencing and project management skills
• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
• Must be willing to travel as required internationally to fulfil the responsibilities of the position.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don't miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now

WuXi Biologics is an equal opportunities employer.