Process Sciences Manager

TAKEDA MANUFACTURING SINGAPORE PTE. LTD.; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

TAKEDA MANUFACTURING SINGAPORE PTE. LTD. invites applications for a senior leadership role to head the Manufacturing Sciences Laboratory on-site in Woodlands.

You will manage budget, lead a capable lab team, plan and execute small-scale studies, and ensure analytical methods meet Takeda standards. You will collaborate with global GMSci teams and drive process improvements. The role requires a strong background in small-scale development, analytical method implementation, DOE and GLP, plus

Qualifications

• Bachelor's degree in a relevant science with minimum 8 years of experience or a Master/PhD with at least 6 years.
• Hands-on in cell culture/upstream and purification/downstream for small-scale manufacturing.
• Experience with analytical methods development and implementation.
• Proven track record in small-scale development, DOE and scale-down models.
• Experience managing people and leading teams in a regulated environment.

Responsibilities

• Lead and supervise the laboratory team, collaborate with internal and global teams to define scope, schedule, budget and resources.
• Ensure compliance with internal/external guidelines for analytical method implementation and testing.
• Coach and develop staff, review protocols and reports, and manage lab data and documentation.
• Support manufacturing operations by providing data from small-scale studies to inform process decisions.
• Implement new technologies and digital solutions aligned with global and site strategies.
• Participate in site leadership activities and drive the laboratory strategy in line with global network aims.

Skills

DOE

Planning & scheduling

Small-scale process development

Analytical methods

GLP

Leadership

Education

Bachelor's degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering

Master's or PhD with relevant experience

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.

Location: Woodlands, Singapore

About the role

Lead the laboratory personnel to manage the Manufacturing Sciences Laboratory within the approved budget to support site and global activities. Lead the laboratory personnel to plan, design and execute upstream and downstream small-scale experiments within the Manufacturing Sciences Laboratory. Ensure that the experiments meet requirements as per local and global Takeda standards, and according to the required Quality standards. Lead the laboratory personnel to plan and implement analytical methods, and to perform analytical testing within the Manufacturing Sciences laboratory. Collaborate and contribute to the Global Manufacturing Sciences (GMSci) community through the Coagulation Factors Laboratory Network Strategy. Coach and develop the laboratory personnel in technical and soft skills. Part of the site extended leadership team

Job Description

• Lead and supervise the laboratory team. Collaborate with both internal and global cross functional teams (GMSci, other Takeda sites) to define the scope, schedule, budget and resources for the laboratory. Guide the team to define the requirements for the laboratory and the studies.
• Responsible for fulfilment of internal and external guidelines for new product/process characterization, analytical method implementation and testing, small scale lab studies/runs/validation and material use tests. Define the quality standards for the laboratory. Guide the laboratory team to implement these quality standards.
• Coach the team to define and plan small scale experiments and tests within the laboratory. Manage resources required for such activities. Review and approve protocols, reports and data generated from the laboratory studies.
• Support manufacturing operations by providing data from small scale studies and data gathering, to support outcome of process deviations, improvements and changes.
• Responsible for establishing scale down models for existing and new products onsite.
• Responsible for technical input and assessment for product characterization, new process technologies and capability build for the laboratory.
• Implement new innovative technologies within the laboratory where applicable, apply these technologies to small scale experiments for large scale process improvement.
• Responsible for establishing analytical requirements for the laboratory for analytical method implementation to support small scale experiments and tests within the laboratory.
• Ensure that the analytical methods are implemented within the laboratory. Manage resources required for analytical testing activities. Lead and/or provide guidance for troubleshooting efforts for issues from analytical method simple mentation and/or testing.
• Collaborate with cross functional teams and support the implementation of digital solutions for manufacturing processes (in alignment with site and global digital roadmap), such as PAT, online testing/monitoring for the site through providing technical input, designing and executing appropriate small-scale experiments to provide supportive data for implementation.
• Lead global initiatives at site level.
• Align the local requirements and strategy with global laboratory network strategy.
• Participate and contribute as local Singapore representative in global discussions. Drive overall laboratory strategy for the site based on global strategy.
• Ensure that lab equipment maintenance are performed and all equipment are working order.
• Implement new equipment in the laboratory as part of new product introduction/technical transfer and capability build /innovation in alignment with local and global strategy.
• Contribute to the site as a member of its extended leadership team through active participation for ELT activities and meetings.
• Coach direct reports in both technical expertise and leadership behaviours. Responsible for conducting regular quality conversations with direct reports, and performance management of direct reports.
• Identify and groom high potential employees for succession planning.
• Responsible for hiring decisions, in alignment with the team structure and requirements.
• Support EHS walkdowns and ensure the laboratory is in compliance with EHS requirements. Ensure that all EHS CAPA are completed on time.
• Support the site in budget planning for the laboratory. Manage the laboratory budget and lab related expenditure.
• 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.

Education and Experience Requirements

• Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 8 years of relevant experience or Master’s/PhD degree with minimum 6 years of relevant experience.
• Hands on experience with cell culture/upstream (perfusion) and purification/downstream for manufacturing processes in small scale environment.
• Hands on experience with analytical methods and method implementation. Analytical method development is an added advantage.
• Hands on experience with small scale process development, experiment DOE and scale down model implementation. Experiences in large scale biologics manufacturing is an added advantage.
• Experience in people management.

Key Skills and Competencies

• Strong knowledge of laboratory Design of Experiment (DOE),planning and scheduling
• Strong understanding of small scale requirement for process validation for eg and not limited to feasibility studies, scale down models, small scale validation, satellite runs.
• Strong technical expertise in small scale process development with ability to coach the team
• Strong technical knowledge in analytical methods implementation, troubleshooting and testing.
• Good knowledge of GLP
• Team player /able to work in matrix environment