Manufacturing Systems Lead (12mth FTC)

at  WuXi Biologics

MANUFACTURING SYSTEMS LEAD (12MTH FTC)

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.

ORGANIZATION DESCRIPTION

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. Our achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination.
WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

DEPARTMENT DESCRIPTION

As Manufacturing Systems Lead, you’ll 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’ll be reporting directly to the Manufacturing Operations Lead (Associate Director). This role is being offered as a 12mth Fixed Term Contract.

KNOWLEDGE/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.
• 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.

OTHER REQUIREMENTS:

• 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 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.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com
  WuXi Biologics is an equal opportunities employer

Qualifications:

• BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Scienc

Essential duties and responsibilities of this role include and are not limited to the following;

• 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 SOPs are in place.
• Ensure all Manufacturing benchtop equipment is 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 supported in regard 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.

Your Profile: The ideal candidate for this position will have the following:

Qualifications:

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