Job description:
Manufacturing Systems Lead 12 Month FTC
Reporting to the Manufacturing Operations Lead (Associate Director), the Manufacturing Systems Lead will play a pivotal role in establishing the Manufacturing Systems team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, LIMS, finite scheduling (Orchestrate) and benchtop equipment.
Essential Duties and Responsibilities
- Key member of Manufacturing Operations team in WuXi Biologics Ireland.
- Provide expert support to the Manufacturing department in the areas of SAP, LIMS, Trackwise and Finite Scheduling.
- Business owner for SAP Production planning.
- Process and System owner for Manufacturing benchtop equipment. Responsibilities in this area will include but are not limited to management of the MFG benchtop support team performance. Maintain an accurate equipment list of benchtop equipment. Ensure all required system SOP’s are in place.
- Ensure all Manufacturing benchtop equipment are maintained in a qualified state by collaborating with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning).
- Ensure the KPI’s for MFG team are achieved in the areas of Manufacturing Systems support.
- Preparation of budget input for areas of responsibility. Track and monitor budget spend on an annual basis.
- Collaborate with MT and MSAT groups on technical transfer and process validation as required.
- Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
- Ensure that the MFG training team are support client auditing and agency inspections.
- Ensure that the MFG training team are supported in regards to benchtop equipment training 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 systems groups and other functional groups to meet the production objectives and timelines.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents
- Responsible for identifying and assessing new models of benchtop and new equipment as required.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Operations Lead
- Lead future initiatives such as electronic batch records, electronic logbooks, etc. 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.
Person specification
- Ideally, experienced in establishing a Manufacturing department and building a team in a ‘greenfield’ context of similar size and scale.
Experience
- More than 5 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 with electronic batch records a distinct advantage
- Experience in working with the cross-functional teams.
- Experience with GMP systems such as SAP and Benchtop equipment qualification and operation etc.
- Strong team lead with the demonstrated ability to manage and support manufacturing operations in a flexible and dynamic team environment
Knowledge
- A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
- The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
- Knowledge of GMP systems such as SAP and Benchtop equipment qualification and operation etc.
- Ideally knowledge and experience of scheduling software including Orchestrate
Qualifications
- BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science
Behavioural Competencies
- A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
- 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
WuXi Biologics is an Equal Opportunities Employer.