Job Description Summary

• The role is responsible for providing leadership and oversight to all routine operational and administrative activities which occur within the individual’s team.
• Operationally, this includes ensuring key interfaces with the department such as Quality Assurance (QA), Engineering (ENG), Manufacturing Science and Technology (MSAT) are well fronted on daily basis to ensure smooth day-to-day running. In addition, the individual is expected to drive consistency between the different teams within the department and to mediate/resolve conflicts across functions.
• Administratively, the individual is responsible for measuring the team’s performance against the Key Performance Indicators (KPIs) of the Department and to drive continuous improvements efforts.

Responsibilities:

• Ensure team’s competencies in performing the following tasks: Dispensing of raw materials; kitting of traceables; washing/ sanitization of parts/ equipment; autoclaving of assemblies;
• Provide oversight for onsite third-party cleaning contractors to ensure activities such as area cleaning/ sanitization; waste removal; replenishment of supplies e.g. cleanroom gowns/ scrubs, low-lint wipes, 70% sterile IPA, hand sanitizers etc. are performed;
• Ensure team’s competencies in performing the following tasks: buffer/ media Preparation, filter installation/ integrity testing
• Perform sample preparation and submission
• Perform laboratory tasks including but not limited to sampling, pH and conductivity, measurements
• Perform daily review of production or deviation or batch record schedule and allocate the appropriate resource to ensure all objectives within the team are met
• Determine priorities and critical actions within individual team in collaboration with respective manager
• Ensure total readiness of manufacturing suites, including housekeeping, materials and documents e.g. batch records to support shift requirements and any off-shift needs for the day
• Expert in system user of business systems such as SAP, DeltaV, Trackwise, etc
• Involve in the deviation investigation, batch record review and TrackWise documentation. Possess TrackWise Supervisory access
• Provide necessary guidance and assistance in problems solving and issues resolution, including appropriate escalation where needed
• Provide on-the-job training through Performance Measure (PM) to support formalized technical and GMP training Lead GMP and Safety audits
• Provide oversight to the proper equipment housekeeping on the shop floor

Requirement:

• With manufacturing support working experience in bio-pharm/ APIs industry in GMP, familiar with biology production process in GMP;
• Junior College above, major in biology, bio-pharmacy related.
• Good at communication and teamwork internally and externally. Good analytical and problem solve skills.
• Prefer with team management experience. Rich experience in organizing & planning assigned daily activities to subordinates and ensure timely completion of all assignments.
• Good English in written and oral.
  

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