Job Description

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Job Title: Process Knowledge & Control Lead
Location: Woodlands, Singapore

About the role:

• Implement and maintain process monitoring tools on site, for eg, and not limited to, MVDA, SIMCA online to support CPV programs and proactive process monitoring
• Lead continuous process verification (CPV) for the site
• Lead continuous process improvement projects [Quality by Design (QbD), Process Analytical technology (PAT)] as part of the Takeda and site digital roadmap. Implement and lead QbD and PAT on site.
• Support digital roadmap for the site and as part of the Takeda organization and implement digital solutions for Manufacturing Sciences (MSci) and manufacturing processes for the site
• Represents MSci in global Data, Digital & Technology (DD&T) community of practice (CoP) and in global projects, discussions, where applicable

How you will contribute:

• Lead, coordinate and execute QbD, process monitoring / trending, PAT and digital activities for manufacturing processes at the site.
• Support the deployment of process knowledge and control from strategy to local implementation. Represents MSci and provide inputs to the global owners where applicable.
• Lead QbD and digital initiatives linked to proactive process monitoring at site, as part of the control strategy from site\xe2\x80\x99s process risk assessments.
• Own and lead the process monitoring and trending activities on site, owns the site\xe2\x80\x99s CPV plan and facilitates CPV activities on site.
• Act as technical subject matter expert (SME) for modelling tools used for manufacturing processes on site: for eg and not limited to: minitab, discoverant, SIMCA online. Implement PAT tools on site for new technology implementation, process improvement and process troubleshooting.
• Lead the MSci team in the use of modelling and digital tools such as MVDA, Discoverant, PAT as part of the CPV program, for site digital roadmap implementation where applicable and for process improvements/troubleshooting.
• Represents local MSci for global initiatives implementation related to PKC/ QbD /Modelling for process monitoring: function as site contact in global meetings or DD&T CoP on PKC/QbD/PAT/digital sciences related to manufacturing processes or innovative technologies for manufacturing processes.
• Drive data preparation for process parameters indicators for annual product review (APR/APQR) with the support of MSci engineers.
• 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

• Bachelor\xe2\x80\x99s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 6 years of relevant experience or Master\xe2\x80\x99s/PhD degree with minimum 4 years of relevant experience.
• Hands on experience in data or digital sciences, CPV, modelling and PAT within pharmaceutical manufacturing environment.
• Experience in manufacturing processes in pharmaceutical manufacturing environment. Experience in biologics manufacturing (cell culture processes or downstream purification) is an added advantage.
• Has good knowledge of cGMPs

Key Skills and Competencies

• Strong technical proficiency in PAT knowledge and tools, QbD concept, CPV concept and principles as per ICH and Health Authorities requirement
• Strong technical proficiency in modelling/ statistical tools such as Minitab, Discoverant, SIMCA online and its applications in pharmaceutical manufacturing environment
• Strong technical knowledge in proactive proactive monitoring and its applications in pharmaceutical manufacturing.
• Strong communication, stake holder management, project management and conflict resolutions skills
• Willingness to learn
• Team worker/ able to work in matrix environment
• Independent worker/ Self starter

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