Shire Microbiologist I in Woodlands Industrial Park (Baxalta), Singapore

This position is involved in maintaining and optimizing Quality Systems in Microbiology/ Sterility Assurance Lab. In addition, this position is also required to perform routine microbiological testing using validated test methods and qualified instruments when required.

Lab Maintenance (System)

  • A Subject Matter Expect (SME) of Microbiological/ Sterility Assurance tests.

  • Lead and conduct method trainings to new lab personnel.

  • Initiate and investigate GEMS event via Trackwise system and Laboratory Investigation Report (LIR).

  • Participate in cross functional root cause analysis (RCA) during investigation.

  • Perform review and approval on QC test results.

  • Involve in audit preparation and ready to present during an inspection.

  • Lead a Lean Green Belt (LGB) project when tasked.

  • Lead a cost saving project when tasked.

  • Participate and perform method validation/ study when tasked.

  • Require to write different types of reports, such as trend report, technical or study report, memo, validation report, investigation report etc.

  • Revise Standard Operating Procedures (SOP) and EHS Risk Assessment.

  • Perform data compilation and trending on a monthly basis when required.

  • Have a good understanding on 5S methodology and able to transform an area using 5S methodology;

  • Vigilantly report/ highlight issues or unsafe act.

  • Ensure and maintain good housekeeping; ensure sufficient inventory to prevent any delays in testing.

Lab Maintenance (Instrument)

  • Perform preventive maintenance for laboratory equipment, such as Temperature Controlled Object (TCO), Biosafety Cabinet (BSC), etc.

  • Responsible for ownership of sophisticated lab equipment and conduct training to respective lab personnel.

  • Arrange equipment calibration with external vendor.

  • Manage and maintain service contract with vendor when required.

  • Perform peer review on equipment logbook.

Routine Testing

  • Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT), Biological Indicator (BI) testing, microbial identification (ID), environment monitoring (EM), and plate reading.

  • Microbiological sample types include critical utilities, in-process/ Bulk Drug Substances (BDS), raw materials, investigational non-routine samples.

  • Perform sterilization cycle using qualified autoclave; perform depyrogenation using qualified cycle.

  • Perform aliquoting on Process and Non-Protein samples on a daily basis.

  • Support Lab Services team on replenishment of inventory from warehouse on a weekly basis.General Responsibilities

  • Responsibility to adhere to any applicable EHS requirements.

  • Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.

  • Any other duties as assigned by supervisor.

  • Bachelor Degree in Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent, preferably with 1-2 years of experience in cGMP Pharmaceutical, Biopharmaceutical or related manufacturing environment and/ or related laboratory experience.

  • Diploma in Microbiology, Biological Sciences, Life Sciences, Biotechnology with minimal 6 years of related cGMP laboratory experience.

  • Experience in performing QC testing.

  • Preferably Experience in conducting microbiological study, investigation and cost saving projects etc.

Technical Skills

  • Knowledgeable and expect of assigned subject matter.

  • Able to conduct training to new comer in an understandable manner.

  • Knowledge in cGMP quality system and industry guidelines e.g. GEMS, Change Control, release, documentation etc.

  • Organized and detailed oriented to drive completion of assigned tasks.

  • Able to solve problem with sound analytical thinking.

  • Able to propose ideas/ suggestion during a cross functional meeting or discussion.

  • Knowledge with Microsoft Office applications.

  • Knowledge of Safety principles, practices, regulations and procedure related to the work.

Mindset & Behavior

  • Committed to the role assigned.

  • Positive mindset and motivated.

  • Able to understand constraints at times and be flexible.

  • Good Interpersonal, Verbal and Written Communication Skills required.

  • Ability to work and collaborate within the team.

  • Mature and independent employee who require minimal guidance from QC Lead.

  • Good in emotional handling.

  • Good time management skills

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.