Shire Chemist I (Analytical) in Woodlands Industrial Park (Baxalta), Singapore
This position is required perform all tasks associated with the QC analytical lab operations which include chemical analysis, biochemical analysis, equipment calibration/maintenance, records review, records approval, deviation/investigation write up/review, equipment qualification, method validation, method transfer and other tasks as assigned.
Perform chemistry, biochemistry analysis of in-process samples, bulk drug substance (BDS), non-routine samples.
Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures
Perform equipment calibration and maintenance.
Perform review/approval of QC records/ log books.
Perform trending of lab results.
Initiate and participate in Out Of Specification (OOS), Invalid test and Lab Deviation Investigation Write-Up and assist in timely closure of laboratory invalid results, lab investigation and CAPA.
Write/revise SOPs, forms, training qualifications (TQ) and risk assessments (RA).
Act as a Subject Matter Expert (SME) to provide technical advice to QC Personnel in laboratory related troubleshooting e.g. lab equipment failure, method
Provide appropriate training for the QC Analytical Team.
Participate in method validation/ transfer or equipment qualification when necessary
Ensure proper, safe handling and disposal of waste; ensuring a safe working environment.General Responsibilities:
Carry out 5S and ensures good housekeeping of Analytical Lab area.
Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk).
Participate in projects towards improving safety performance and continuous improvement initiatives.
QC Chemist may cover for another QC Chemist of similar functions/areas in his/her absence by signing documents on his/her behalf.
Assist Supervisor to support internal and external compliance audits.
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.
Education and Experience Requirements
Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent, preferably with more than 1 year of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.
Project Management Skills
Organization and planning skills
Analytical and Logical thinking skills
Ability to work and collaborate within the team
Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
Knowledge in Ion Chromatography (IC), High Performance Liquid Chromatography (HPLC), Fluorescence spectrometer (FLS), pH, Conductivity, Gel electrophoresis (SDS Page or Western Blot), Potency and ELISA
Knowledge in Empower and LIMS.
Knowledge in Microsoft Office.
Solves problems and implements corrective actions using six sigma tools.
Be a subject matter expert in given areas of responsibilities and able to solve issues related to his/her area of expertise.
Some knowledge in safety principles, practices, regulations and procedure related to the work.
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.