Biotechnologist 3, Mfg
Lonza
Tuas, Singapore,SG
38d ago

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision :

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission :

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary

The Biotechnologist is responsible for the manufacture of therapeutic proteins under cGMP

conditions. This position reports to the Senior / Section Lead / Manager of the Small Scale Manufacturing 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 (e.g. sampling, pH / conductivity / osmolality measurement etc.)
  • Perform routine sanitization tasks to maintain facility standards
  • Achieve & consistently maintain a training status of 90%
  • Demonstrate aseptic technique in the handling of product / materials
  • Attain full competency in the performance of all operations relevant to manufacturing areas assigned
  • Attain 100% trainer qualifications in identified area of specialization
  • Able to make decisions based on significant knowledge & experience
  • Display superior process & equipment troubleshooting ability under routine scenarios
  • Provide coaching and mentoring to Biotechnologist 1 / 2 where applicable
  • Technical Process Expertise

  • Exhibit basic understanding of critical process / operational parameters and target / acceptable ranges
  • Exhibit detailed understanding of the entire process e.g. interactions between different process parameters
  • Understand process flow from scheduling & resource loading perspective
  • Display in-depth awareness of operational factors which influence the process
  • Systems & cGMP Expertise

  • Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) effectively & competently
  • Initiate clear & concise Minor Deviations with or without guidance
  • 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 document change workflow overview & ability to initiate Document Change Forms (DCFs).
  • 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, historian data retrieval / trending / printing
  • Able to differentiate Minor Deviations / Major Deviations / Critical Deviations
  • Assist in providing initial drafts for the write-ups to Minor Deviations
  • Able to independently complete document changes e.g. SOPs revisions
  • Raise & follow through to completion Work Notifications
  • Understand emergency materials requisition process / workflow
  • Complete Environmental Alert / Action Reports (EARs)
  • Initiate Quality Tag-outs
  • Initiate Change Requests, Planned Deviations and / or Computer Systems Change Controls (CSCCs)
  • Plan & execute validation activities as required
  • Acquire PWCS System Expert Access & is recognized as a PWCS system expert
  • Acquire TrackWise Supervisory Access & is recognized as being competent in addressing and / or reviewing Minor Deviations
  • Cell Culture

  • Intermediate skill and knowledge of aseptic technique for subculture stages example using culture flask, spinners, wave bioreactors, etc
  • Intermediate technical knowledge on the bioreactor culture control example pH / DO control, CO2 / O2 control, cell performance, and metabolites analysis.
  • 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 impact operations, product quality and / or safety & escalate to the appropriate level of attention Exhibit proven logic &
  • decision making abilities in multiple scenarios

    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 (i.e. within CIP / SIP expiries) in advance of scheduled usage
  • Communicate to a level where appropriate questions are asked to increase understanding of role
  • Present facts in a logical, concise & accurate manner while checking for understanding
  • Being offering suggestions / options to Section Lead / Manager on process / scheduling issues
  • Support Operational Excellence (OE) visual management tools & systems
  • Write & perform shift exchange in the absence of Section Lead / Manager
  • Manage multiple and / or changing priorities of floor activities
  • Forecast & plan for upcoming suite activities & actively coordinate with other departments
  • Offer and implement improvement suggestions relating to process / scheduling / costs / operational workflows
  • 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
  • Requirements :

  • Preferably with at least 2 years of relevant work experience in a similar industry
  • Degree / Diploma / NITEC in a related Science / Engineering discipline
  • Knowledge of Biopharmaceutical processing is an added asset
  • Knowledge of cGMP applications
  • Positive team oriented attitude
  • Strong communication and interpersonal skills
  • Willing to perform rotating 12-hour shift pattern
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