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Life at Takeda
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Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
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Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
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Biotechnologist IIIApply Now
Primary Objectives of this Job
With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture and Purification areas. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products.
Job Function and Description
Primary responsibilities include:
- 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
- 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 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
- Propose document revisions
- Complete required training on time
- Carry out work in a safe manner, notifying management of safety issues and risks
The individual will manage equipment and support facility related projects by
- Perform scheduled cleaning of equipment
- Assist in the assembly and disassembly of process equipment
- Perform standardization of equipment
- Perform basic 5S housekeeping
- Initiate Corrective Work Orders in the C3ME system or equivalent system
- Support change over activities
Staff Technical Training and Development
- Meet and maintain training requirements
- Develop and maintain personal development plan
- 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’s Code of Conduct.
- Any other duties as assigned by supervisor.
Education and Experience Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related
- 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 more than 2 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or related with more than 5 years of relevant experience in the biotechnology, pharmaceutical industry
- Will work holidays and overtime as required
- May be required to adjust work schedule to meet production demands
Key Skills and Competencies
- May be required to perform as a subject matter expert for equipment and/or systems
- Ability to following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable
- Possess good communication skills
- Possess good troubleshooting skills
- Full awareness of current Good Manufacturing Practices (cGMP)
- Proficient documentation and proficient computer skills
- Proficient in aseptic technique where applicable
- 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)
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.
Job ID SR0043951