Senior Biotechnologist I

1 week ago


Singapur, Singapore Takeda Full time

About the Role:

Takeda is seeking a highly skilled and motivated Senior Biotechnologist I to join our team in Singapore. As a Senior Biotechnologist I, you will be responsible for performing routine and critical manufacturing operations, including work functions in Cell Culture and Purification areas. You will operate production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products. You will also support engineering and validation activities.

Key Responsibilities:

  • Execution of routine and critical production operations
  • Learn and perform well-defined SOPs
  • Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
  • Execute instructions and record data in the Electronic Batch Management (EBM) system if applicable
  • Execute instructions and record data in the Master Batch Records (MBRs) and Master Formulation Records (MFRs) if applicable
  • Review manufacturing documentation and EBM or PCS alerts real-time to ensure compliance if applicable
  • Attain operating knowledge of the Process Control System (PCS)
  • Record data into logbooks and log-sheets
  • Review logbooks and log-sheets data
  • Perform equipment monitoring
  • Perform and coordinate basic laboratory tasks including but not limited to sampling, pH and conductivity measurements
  • Demonstrate aseptic technique in the handling of product and materials if applicable
  • Troubleshoot and resolve process related issues
  • Initiate and document production events in the Global Event Management System (GEMS) or equivalent system
  • Informing management of events impacting production schedule
  • Propose and review document revisions
  • Complete required training on time
  • Carry out work in a safe manner, notifying management of safety issues and risks

Requirements:

  • Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry
  • 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 and possess 4 - 6 years of relevant experience in the biotechnology or pharmaceutical industry
  • Nitec in Biotechnology / Chemical Process Technology or related with 6 - 8 years of relevant experience in the biotechnology, pharmaceutical industry
  • Excellent self-motivated team player with hands-on attitude and good communication skills
  • Able to work on rotating shift
  • Will work holidays and overtime as required
  • May be required to adjust work schedule to meet production demands

Key Skills and Competencies:

  • Will be required to perform as a subject matter expert for equipment and/or systems
  • Proficient at following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable
  • Possess excellent communication skills
  • Possess excellent troubleshooting skills
  • Full awareness of current Good Manufacturing Practices (cGMP)
  • Proficient documentation and proficient computer skills
  • Proficient in aseptic technique where applicable
  • Experience as a system user of business systems such as C3ME and Trackwise
  • Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
  • Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
  • Ability to work in and out of 2-8 deg C Cold Rooms with appropriate personal protective equipment if required
  • Ability to work in confined spaces if required
  • Ability to work around chemicals (alcohols, acids & bases)


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