Job Description

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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 companys Biologics Operating Unit network, the site is Takedas only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takedas first positive energy building certified by Singapores Building and Construction Authoritys Green Mark scheme in 2022.

Job Title: Manufacturing Expert
Location: Woodlands, Singapore

About the role:

With some supervision, the individual will support and coordinate routine GMP manufacturing life cycle and day to day operational activities associated with the products and process equipment in Takeda Singapore, including but not limited to Manufacturing Suite 1, Manufacturing Suite 2 and Manufacturing Support areas. In addition, the individual will provide critical ad hoc support to continuous improvement, validation and CAPEX activities.

How you will contribute:

The individual will support the EHS and cGMP compliance of day to day and tactical manufacturing activities and ensuring production activities are executed successfully. Primary responsibilities include: (70%)

• Work hand-in-hand with the shift teams to ensure adherence to the production plan, resolve issues, as required
• Be considered to have more than one area of manufacturing expertise, for example, Upstream processing/Downstream processing/ Equipment Preparation/ Buffer Preparation and/or knowledge in key systems like EBM/XFP/CIP/SIP knowledge
• Act as subject matter expert during audits, explaining and walking through specific process operations or investigations, as applicable
• Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs.
• Be a change control owner in the CCMS system, if applicable
• Coordination of daily activities between shift teams and supporting functions

The individual will manage equipment and support facility related projects by: (20%)

• Able to lead investigations with the support of Operational Excellence or other functions.
• Contribute to continuous improvement

Staff Technical Training and Development: (10%)

• Meet and maintain training requirements on time
• Provide technical training for area personnel, as required
• Develop training material, as required
• Train and coach team members, as required
• Develop and maintain personal development plan
• Participate in site or global strategic initiatives, as required
• Provide feedback to peers to help staff development, as required
• 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 Takedas 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 excellent communication skills
• Able to work on odd hours as required

Key Skills and Competencies

The individual should have good understanding of cGMP manufacturing aspects and had hands-on manufacturing experience.

• Excellent at technical writing as required for Electronic Batch Management (Proficient at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
• Possess good communication and presentation skills.
• Possess good troubleshooting skills and critical thinking.
• Full awareness of current Good Manufacturing Practices (cGMP)
• Proficient documentation skills and computer skills including Microsoft Excel/Word/PowerPoint
• Good time management skills
• Ability to work in a matrix environment.
• Understanding of requirements from support functions and their capabilities
• Experience as a system user of business systems such as C3ME, XFP and Trackwise
• Will work holidays and overtime as required.
• May be required to adjust work schedule to meet production demands.
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Ability to grow and gain entry to biotechnology/pharmaceutical manufacturing areas.
• May be required to stand for 6 hours in a production suite.
• May be required to climb ladders and work platforms.
• May be required to stoop or bend to check or trouble-shoot equipment.
• May be required 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