Chemist I (Analytical)

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Job Description

Company Profile:

Takedas Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the companys Biologics Operating Unit network the site is Takedas only biologics drug substance manufacturing facility in Asia. The facility has two buildings including manufacturing suites and laboratories as well as Takedas first positive energy building certified by Singapores Building and Construction Authoritys Green Mark scheme in 2022.

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.

Core Responsibilities:

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 WriteUp 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 Takedas Code of Conduct.

Any other duties as assigned by supervisor.

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.

Key Skills and Competencies:

Project Management Skills

o Organization and planning skills

o Analytical and Logical thinking skills

o Ability to work and collaborate within the team

Technical Skills:

o Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP EP 21CFR ICH etc. o 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

o Knowledge in Empower and LIMS. o Knowledge in Microsoft Office.

Problem solving:

o 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.

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