Manufacturing Materials Specialist

WuXi Biologics; Leinster; On-site; EUR 60,000 - 90,000; Full time

Job summary

WuXi Biologics Ireland is seeking a Manufacturing Materials Management Specialist to join the Manufacturing Operations group. You will provide expert support in SAP, abnormal material handling, stock cycle counts and material replenishment.

The role requires GMP compliance, collaboration with QA, Warehouse, Finance and SCM, and continuous improvement of SOPs and 5S/Lean practices. You will help drive timely production, support audits, and contribute to building a strong MFG Materials Team.

Qualifications

• Minimum 2 years in biopharmaceutical manufacturing.
• Experience with FDA/EMA/CFDA regulatory environments.
• Experience with GMP systems such as SAP and TrackWise.
• Knowledge of deviations, investigations, CAPA and change control.
• Experience working with cross-functional teams.

Responsibilities

• Support SAP, Abnormal Material Handling, Supplier Complaints, Stock Cycle Counts, Return of Materials to Warehouse and Material Replenishment activities.
• Ensure GMP compliance and support client audits/inspections and deviation investigations.
• Collaborate with QA, Warehouse, Finance and SCM on Material Management activities.
• Maintain 5S & Lean housekeeping and continuous improvement of storage areas.
• Coordinate with MFG Materials Team to meet production objectives and timelines.

Skills

Communication skills

Cross-functional teamwork

Proactivity

Education

BSc/MSc/PhD in Chemical Engineering or related field

Tools

SAP

TrackWise

Orchestrate

Job description

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
• 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
• 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!

WuXi Biologics is an equal opportunities employer.