CCP5 Trainee

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

Responsibilities
The Biotechnologist is responsible for the manufacture of therapeutic proteins under cGMP conditions. Expectations for each position are built upon those described in the preceding level. There will be some physical work required to handle equipment and materials. During the course of routine work, the Intern is expected to be working in clean rooms most of the time. This position reports to the Senior/ Section Lead/ Manager of the Manufacturing Large Scale, Small Scale or Centralized Operations Team.

Equipment Expertise

• Learn & perform well defined procedures
• Pursue ongoing training to increase knowledge & understanding
• Attain basic understanding of cGMP requirements & compliance within a GMP manufacturing setting
• Perform assigned tasks (by Section Lead/ Manager) both with and without supervision
• Perform equipment monitoring & and basic 6S housekeeping
• Perform basic laboratory tasks (eg: sampling, pH/ conductivity/ osmolality measurements etc.)
• Perform routine sanitization tasks to maintain facility standards
• Achieve & consistently maintain a training status of ≥ 90%
• 100% trained & signed off on Performance Measures (PMs) relating to CIP/ SIP/ basic tank & instrument operations
• Demonstrate aseptic technique in the handling of product materials
• Perform tasks independently in ≥ 80% of manufacturing areas assigned eg. USP/ DSP/ MEP
• Perform basic process & equipment troubleshooting
• Able to multi-task on equipment preparations & operations to ensure adherence schedule
• Attain full competency in the performance of all operations relevant to manufacturing areas assigned
• 100% trained in all related manufacturing operations
• Display basic process & equipment troubleshooting ability under routine scenarios.

Technical Process Expertise

• Exhibit basic understanding of critical process/ operational parameters and target/ acceptable ranges
• Exhibit basic understanding of the entire process eg. interactions between different process parameters.
• Understand process flow from scheduling & resource loading perspective.
• Display basic awareness of operational factors, which influence the process
• Work effectively interdepartmentally, providing manufacturing insights & support to MSAT, Lot Review and Deviation Investigation groups.

Systems & cGMP Expertise

• Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) effectively & competently.
• Understand in general the Lot Review process/ workflow.
• LIMS (Laboratory Information Management System) trained & competent in the submission of samples via LIMS.
• Attain operating knowledge of PWCS (Plant Wide Control System)
• Understand the deviation system/ workflow overview.
• Understand the Kanban system overview & competent in ordering of consumables, BRs traceable & logbooks
• Perform logbook & 1st level BR review effectively & competently
• Operate PWCS independently for daily routines.
• Understand emergency materials requisition process/ workflow.
• Execute validation activities as per instructed.

Problem Analysis/ Decision Making

• Make basic decisions e.g. know when to seek help & who to contact
• Identify situations which may require further escalation to Section Lead/ Manager.
• Provide appropriate immediate actions in situations, which will require further escalation.
• Recognize abnormal and/ or potential events, which affect operations, product quality and/ or safety & escalate to the appropriate level of attention.

Planning/ Communication

• Organize & plan assigned daily activities to ensure timely completion of all assignments
• Document all work as it occurs
• Ensure all BRs related materials e.g. dispensing, consumables, traceable, cleaned/ autoclaved parts etc. are available in advance of scheduled usage. Ensure all equipment are ready for production use (ie. within CIP/ SIP expires) in advance of scheduled usage.

Supervision Received

• Report to Section Lead/ Manager
• Receive daily supervision on routine work & detailed instructions on new assignments.
• Able to work independently to perform manufacturing activities.
• Receive minimal supervision and ensure job assignments are progressing per schedule.
• Any other duties as assigned by your Supervisor Manager.

Education & Experience

• Degree/ Diploma/ NITEC in a related Science/ Engineering discipline
• Fresh graduates are welcome
• Individual without prior working experience in the biopharmaceutical manufacturing industry is encouraged to apply as training will be provided
• Knowledge of cGMP applications
• Positive team oriented attitude
• Strong communication and interpersonal skills
• Willing to perform rotating 12-hour shift pattern
• • Able to perform physical activities in a clean room environment. Individual will be on the feet most of the time, and will be required to perform manual work (> 60% of activities) in a buddy system that includes standing, carrying items that weigh up to 12 kg, or moving equipment.

Others

• Two-way company transport is provided to various pick-up and drop-off points island wide.