Manufacturing Materials Specialist

As a Manufacturing Materials Management Specialist will play a pivotal role in forming the Manufacturing Materials Team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, Abnormal Material Handling, Return of Materials to Warehouse, Stock Cycle Counts, Supplier Complaints and Material Replenishment activities.

Essential Duties and Responsibilities

• Key member of Manufacturing Operations team in WuXi Biologics Ireland.
• Ensure following EudraLex and all other applicable regulatory cGMP guidelines.
• Provide expert support to the Manufacturing department in the areas of SAP, Abnormal Material Handling, Supplier Complaints, Stock Cycle Counts, Return of Materials to Warehouse and Material Replenishment activities.
• Ensure all required relevant SOPs are in place.
• Ensure all Manufacturing Material Storage Areas are maintained as per good housekeeping practices by collaborating with relevant departments on all aspects of 5S & Lean.
• Ensure the KPI's for MFG team are achieved in the areas of Manufacturing Materials Management.
• Collaborate with QA, Warehouse, Finance and SCM groups on Material Management activities as required.
• Collaborate with QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
• Ensure that the MFG Team are supported in regard to Material Management activities providing support and troubleshooting as needed.
• Ensuring continual improvement of manufacturing documentation (SOP's MBR's, OJT's) for areas of responsibility to ensure they are current, accurate, and clear.
• Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
• Assist the MFG Operations Lead to coordinate the work between the MFG Materials Team and other functional groups to meet the production objectives and timelines.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Operations Lead.
• Execute future initiatives such as 5S and continuous improvement projects for the areas in scope on behalf of Manufacturing.
• 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

Technical Competencies

• Ideally, experienced in establishing a Manufacturing department and building a team in a 'greenfield' context of similar size and scale.

Experience

• More than 2 years in biopharmaceutical manufacturing.
• Ideally, experienced in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
• Experience in working with the cross-functional teams.
• Experience with GMP systems such as SAP and TrackWise etc.

Knowledge

• A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
• Knowledge of GMP systems such as SAP and TrackWise etc.
• Ideally knowledge and experience of scheduling software including Orchestrate.

Qualifications

• BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology, Pharmaceutical Science,
• Biopharmaceutical Science or Analytical Science

Behavioural Competencies

• Excellent verbal and written communication and presentation skills.
• Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
• Ability to work on own initiative and be proactive.
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• Excellent organisational and planning skills and strong attention to detail

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 can 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 mission - 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!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via [email protected]

WuXi Biologics is an equal opportunities employer.