Job Description

By clicking the \xe2\x80\x9cApply\xe2\x80\x9d button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda\xe2\x80\x99s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.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\xe2\x80\x99s Biologics Operating Unit network, the site is Takeda\xe2\x80\x99s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda\xe2\x80\x99s first positive energy building certified by Singapore\xe2\x80\x99s Building and Construction Authority\xe2\x80\x99s Green Mark scheme in 2022.Job Title: Manufacturing Excellence Supervisor
Location: Woodlands, SingaporeAbout the role:

• The individual will provide leadership to the Manufacturing Excellence Cell Culture / Purification team, ensuring routine GMP manufacturing life cycle and day to day operational activities associated with the products and process equipment in the Takeda Singapore Plant, are executed in a timely fashion, including but not limited to Manufacturing Suite 1, Manufacturing Suite 2, and Manufacturing Support areas. In addition, the individual will provide lead key initiatives not limited to continuous improvement, validation and CAPEX activities.

How you will contribute:Primary responsibilities (70%):

• Prioritize and lead all manufacturing Improvement initiatives.
• Demonstrate competency and understand interactions / complexity of all areas of manufacturing expertise, for example, Upstream processing / Downstream processing / Equipment Preparation / Buffer Preparation
• Demonstrate understanding of various products and their respective processes.
• Act as subject matter expert during audits, explaining and walking through specific process operations or investigations, as applicable.
• Manage deviations closure under team\xe2\x80\x99s ownership, including product impact assessments and implement CAPAs.
• Manage change controls under the team\xe2\x80\x99s ownership, including impact assessments.
• Lead the transfer / implementation of new processes and commissioning & validation activities of new projects, as required.
• Lead complex investigations (e.g. use of statistical tools), as required.
• Able to interpret and manage process model to standard workload.
• Lead continuous improvement initiatives of higher complexity, as required.
• Provide supervisory oversight of events impacting production schedule.
• Provide supervisory oversight of key issues, matrices and deliverables.
• Carry out work in a safe manner, notifying management of safety issues and risks.

Staff Technical Training and Development (20%):

• Meet and maintain training requirements on time.
• Provide technical training for area personnel, as required.
• Develop training material, as required.
• Mentor and train team members, identify gaps and staff improvement requirements.
• Ensure team knowledge and competency are maintained.
• Assume recognition and disciplinary responsibility for direct reports.
• 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.

Ad-hoc and Strategic activities (10%)

• Manage audit preparation under team\xe2\x80\x99s ownership as well as documentation related to audit responses, Adverse event notification review and Annual Product Reviews, as required.
• Develop systems to monitor and analyze processing parameters for atypical trends and improvement opportunities.
• Provide supervisory oversight over product changeover activities.
• Acts as a delegate to the Head of Manufacturing Excellence.

Others:

• 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 RequirementsDegree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses at least 7 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 at least 10 years of relevant experience in the biotechnology or pharmaceutical industry.Nitec in Biotechnology / Chemical Process Technology or related with at least 12 years of relevant experience in the biotechnology, pharmaceutical industry.At least 1 year of supervisor experience in the biotechnology or pharmaceutical industryExcellent self-motivated team player with hands-on attitude and excellent communication skillsWill work holidays and overtime as required.May be required to adjust work schedule to meet production demands.Key Skills and CompetenciesExcellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).Possess excellent communication and presentation skills.Good leadership skills with hands-on attitudeGood interpersonal skills to engage stakeholders from different functions at different levels.Possess excellent critical thinking skills.Full awareness of current Good Manufacturing Practices (cGMP)Proficient documentation skills and computer skills including Microsoft Excel/Word / PowerPointAble to lead cross functional and global teams.Be an agent for manufacturing change and improvement.Ability to work in a matrix environment.Understanding of requirements from support functions and their capabilitiesExperience as a system user of business systems such as C3ME, XFP and Track wise.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.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.LocationsSGP - Singapore - WoodlandsWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Takeda