Job Description Summary
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.
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%
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
Technical Process Expertise
Exhibit basic understanding of critical process/ operational parameters and target/acceptable ranges
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 traceables & logbooks
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
Communicate to a level where appropriate questions are asked to increase understanding of role
Report to Section Lead/ Manager
Receive daily supervision on routine work & detailed instructions on new assignments
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
All Lonza Biologics Employees have the following responsibilities:
Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs.
All personnel are responsible for notifying responsible Management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.)
All personnel should practice good sanitation and health habits.
Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.
All personnel are required to provide support in maintaining the site safety, health and environmental programs and system.
Adherence to SHE rules and regulations is required at all times.