Job Description

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Job Title: Senior Biotechnologist II
Location: Woodlands, Singapore

About the role:

With minimal 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 or lead engineering and validation activities. The individual will deliver excellence in manufacturing processing and provide support in integrate best practices, where appropriate, into manufacturing.

How you will contribute:

70% - Primary responsibilities include:

Oversight and execution of all routine and critical operations as well as commissioning and validation activities

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

Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, EBM, batch records, etc.)

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

Point of contact to troubleshoot, resolve or escalate process related issues

Informing management of events impacting production schedule

Propose and review document revisions

Recommend/Implement process changes/improvements or safety/ergonomic improvements.

Complete required training on timeCarry out work in a safe manner, notifying management of safety issues and risks

20%

Act as a role model (Lead by Example)

Act as a Subject Matter Expert SME for improvement projects

Act as a resource / SME for staff

Provide technical training for area personnel and assess training effectiveness

Develop training material for technical training

Assess staff skill sets and provide feedback to Supervisor

Perform scheduled cleaning of equipment

Assist in the assembly and disassembly of process equipment

Perform standardization of equipment

Perform basic 5S housekeeping

Initiate and follow up on Corrective Work Orders in the C3ME system or equivalent system

Support change over activities

10%

Quality

Lead and participate in investigations of production events in the Global Event Management System (GEMS) or equivalent systems and work with cross-functional departments to identify root causes.

Complete action items for event investigations

Implement appropriate CAPAs from event investigations

Review document revisions of Standard Operating Procedures/Batch Records

Communicate any quality issues/concerns to Supervisor and QA

Implement Change Controls for production

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\xe2\x80\x99s 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 more than 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 more than 6 years of relevant experience in the biotechnology or pharmaceutical industry

Nitec in Biotechnology / Chemical Process Technology or related with more than 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

Knowledge of cGMP\xe2\x80\x99s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.

Proficient at following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable

Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner. In the absence of the supervisor, they are the person of authority.

Expected to act on behalf of the supervisor while on the floor

Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.

Possess excellent communication skills to all levels throughout the organization

Possess excellent troubleshooting skills

Proficient documentation and proficient computer skills

Proficient in aseptic technique where applicable

Proficient 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.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Takeda