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　　Job Description

　　Job Description

　　Takeda's 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 company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

　　Job Title: Biotechnologist

　　Location: Woodlands, Singapore

　　About the role:

　　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.

　　How you will contribute:

　　80% - 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

　　10% - 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

　　10% - 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

　　What you bring to Takeda:

　　Education and Experience Requirements

　　Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possess 0 - 2 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 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry

　　Nitec in Biotechnology / Chemical Process Technology or related with 4 - 6 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)

　　More about us:

　　At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

　　Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

　　Empowering our people to shine:

　　Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

　　Locations

　　SGP - Singapore - Woodlands

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time