Posted to MedZilla on 5/19/2019

Takeda Pharmaceuticals

Singapore-, Biotechnologist II SR0033425-MZ


Primary Objectives

With direct supervision, the individual will:

  • Perform routine manufacturing operations.
  • Operate production equipment according to Standard Operating Procedures (SOPs), Process Control System (PCS), Electronic Batch Records (EBM), Master Formulation Record (MFR) and Checklists/Forms for the production of commercial and/or clinical products.
  • Provide buffer preparation support for manufacturing processes in according to EHS guidelines and in a cGMP compliant manner.

Key Responsibilities

  • Perform routine and non-routine production operations as per MFR/EBM (if required).
  • Perform well-defined SOPs.
  • Execute instructions and record data in the EBM system.
  • Perform Clean In Place (CIP) /Steam In Place (SIP) activities as per MFR/SOP.
  • Perform filter integrity testing (FIT).
  • Perform filtration and filter management as per SOP.
  • Attain operating knowledge on the Process Control System (PCS).
  • Attain operating knowledge on the Manufacturing Execution System (MES).
  • Perform equipment cleaning as per SOP.
  • Perform equipment monitoring.
  • Perform scheduled cleaning of equipment.
  • Perform laboratory tasks including but not limited to sampling, pH, conductivity and refractometer measurements (if required).
  • Pursue on-the-job training through Competency Assessments to increase knowledge and understanding.
  • Record data into logbooks, log-sheets and forms (if applicable).
  • Support Alarm/Alert monitoring and report atypical event (if required).
  • Perform real time trouble-shooting(if required).
  • To participate and resolve process related issues (if required).
  • Demonstrate good cleanroom technique in the handling of product and materials.
  • Support GMP and Safety audits (if required).
  • Perform standardization of equipment (if required).
  • Perform 5S housekeeping.
  • Support transfer of new processes and commission/validation of new projects (if required).
  • Carry out work in a safe manner, notifying management of safety issues and risks.
  • Involve in hands-on execution of the plant operations and assist Supervisors in trouble-shooting.
  • Actively support continuous improvement initiatives.
  • Perform dispensing activities as per Work Order.
  • Perform material transportation as per SOP.
  • Perform material charging as per MFR/EBM.
  • Perform buffer storage activities as per MFR/SOP.

Other Responsibilities

  • Support routine safety and GMP walk down and responding to findings (if required).
  • Support execution of Corrective/Preventive actions which identified (if required).
  • Support change control activities which assigned (if required).
  • Meet and maintain training requirements.
  • Complete assigned training on time.
  • Provide technical training for area personnel.
  • Provide input on training material development.
  • Provide annual performance self-assessment on development plan.
  • Responsibility to adhere to any applicable EHS requirements.
  • Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda values and behaviors.
  • Any other duties as assigned by supervisor.

Education and Experience Requirements

  • Diploma in Applied Chemistry, Biomedical Sciences, Chemical Engineering, Food Science & Technology, Biologics & Process Technology, Chemical & Pharmaceutical Technology, Food Science & Nutrition, Molecular Biotechnology, Biotechnology, Chemical & Biomolecular Engineering, Pharmacy Science or related.

  • Up to one year of relevant experience in the biotechnology, pharmaceutical industry.

  • Nitec in Biotechnology / Chemical Process Technology or related with minimum three years of relevant experience in the biotechnology, pharmaceutical industry.

  • Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation.

  • Experience in ERP/MES/control systems applications will be an added advantage.

  • Able to work on rotating shifts.

  • Able to support overtime as required.

  • Able to support production demands with adjusted work schedule.

  • Able to adhere to EHS/GMP requirement.

  • Ability to wear appropriate PPE/Cleanroom gowning as per SOP.

  • Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

  • Ability to lift, pull or push equipment requiring up to 20kg.

  • Able to work in cold environment (2-8 degrees C).

  • Able to climb ladders and work on platforms.

  • Able to perform confine space entrant/attendant (if required).

Key Skills and Competencies

  • Moderate understanding of general job aspects and moderate understanding of the detailed aspects of the job.
  • Possess good communication skills.
  • Possess basic documentation and computer skills.
  • Possess basic troubleshooting skills.
  • Familiar with current Good Manufacturing Practices (cGMP).
  • Able to take initiative with good problem solving skills.

  • Excellent team player with hands-on attitude.

  • Ability to read/understand Safety Data Sheet (SDS) and handle chemicals as per SOP.
  • Ability to monitor and analyze processing parameters and report atypical trends.
  • Ability to support Continuous Improvement Projects.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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