Shire Sr Lab Analyst I, Micro in Woodlands Industrial Park (Baxalta), Singapore
This position is to perform routine chemical, biochemical, microbiological analysis using written and approved test method SOPs and qualified instrumentation.
During the startup phase and subsequent technology transfer, execute tests as per method validation protocol and method transfer protocol.
Perform chemical/biochemical/microbiological testing on raw materials, in-process samples, finished API, stability samples as per approved test method SOP.
Perform microbiological testing such as bio burden test, endotoxin test, Identification of Microorganism etc
Perform Viable, non-Viable, Surface monitoring in the Cleanroom.
Perform calibration and maintenance of laboratory equipment.
Participate in all activities associated with 5S in the laboratory.
Assist in the writing of SOPs.
Conduct training for fellow QC Colleagues.
Assist the QC Supervisor in Chemical and Consumable Inventory Management
Initiate Laboratory deviation report and OOS report.
Assist the QC Supervisor in performing trending of data.
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.
Diploma in Chemistry, Biochemistry, Biotechnology or equivalent
Ability to work and collaborate within the team.
Good analytical and instrumentation techniques.
Experience in performing testing using analytical instrumentation such as HPLC, UV-Vis Spectrophotometer, FTIR
Experience in microbiological testing such as bioburden test, endotoxin test, viable/non viable monitoring, ID testing of organism
Good planning and organization skill
Analytical and Logical thinking skills
Has good knowledge in the field of chemistry, microbiology, biotechnology and/or pharmacy.
Knowledge in Microsoft Office.
Ability to troubleshoot lab equipment failure and test method issues.
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.