Senior Biotech (Suite 2)

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Job Description

Company Profile:

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: Senior Biotech I (Suite 2)
Location: Woodlands, Singapore

About the role:

• With limited 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. Will support engineering and validation activities.

How you will contribute:

75% 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.
• 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

15% The individual will manage equipment and support facility related projects by:

• Act as a Subject Matter Expert SME for improvement projects.
• 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

10% Staff Technical Training and Development:

• Meet and maintain training requirements.
• Provide technical training for area personnel.
• Provide input on training material development.
• Develop and maintain personal development plan.
• Provide annual performance self-assessment on development plan.

Others:

• 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 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)

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.

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