## **Overview** Manufacturing Sciences, Analytics and Technology (MSAT) drives the industrialization and continuous improvement of biological processes and products. The function embraces new technologies and digital innovations while serving as the custodian of manufacturing process knowledge. Positioned at the intersection of R&D and manufacturing, MSAT is a multidisciplinary function providing expertise in process sciences, manufacturing, process modelling, statistical analysis, validation, and technology transfer. The **Scientist II, Upstream MSAT Laboratory (Modulus Singapore)** is responsible for independently designing and executing laboratory studies to support manufacturing troubleshooting, technology transfer, and lifecycle management for commercial biologics production. The role also contributes to the evaluation of emerging and innovative technologies, including automation. Working closely with MSAT process engineers, this position translates manufacturing challenges into robust laboratory study designs, authors protocols and reports, and executes experiments with scientific rigor. The role operates with a high degree of autonomy, under the strategic guidance of the MSAT Laboratory Manager, and may require flexible working hours, including after-hours support when needed. ## **Key Responsibilities** ### **1. Laboratory Studies & Scientific Execution** - Design and execute small- to mid-scale upstream laboratory studies supporting manufacturing investigations, technology transfer, and process improvements. - Collaborate with MSAT process engineers to define study objectives and develop robust experimental designs. - Author study plans, protocols, reports, and technical documentation in compliance with GLP standards. - Analyze and interpret experimental data, draw scientifically sound conclusions, and present findings to cross-functional stakeholders. - Ensure all laboratory activities are conducted safely, within scope, and on schedule. ### **2. Manufacturing Support & Troubleshooting** - Provide upstream scientific expertise to support manufacturing investigations. - Design and execute studies for root cause analysis and CAPA development. - Support urgent and time-sensitive activities, including flexible hours or weekend work where required. - Contribute to after-hours support for critical manufacturing issues. ### **3. Laboratory Operations** - Maintain laboratory readiness, including equipment setup, cleaning, maintenance, and coordination with vendors and engineering teams. - Manage inventory of materials and consumables, including procurement and stock monitoring. - Maintain accurate laboratory documentation (e.g., logbooks, inventory records) and ensure compliance with GLP and HSE standards. - Review and approve operational documentation to ensure compliance. ### **4. Technology Transfer Support** - Support technology transfer activities through execution of laboratory studies (e.g., scale-down model qualification, bridging studies). - Contribute to drafting and compilation of technology transfer documentation. - Promote standardization and knowledge management practices within the site and global network. ### **5. Lifecycle Management & Continuous Improvement** - Analyze laboratory and manufacturing data trends to identify improvement opportunities. - Support process optimization and continuous improvement initiatives. - Stay updated on industry trends and emerging upstream technologies, recommending enhancements where appropriate. - Author documentation supporting change management, including risk assessments and mitigation strategies. ### **6. Mentorship & Team Contribution** - Mentor trainees and interns on laboratory techniques, scientific thinking, and GLP practices. - Contribute to a collaborative and high-performance laboratory environment. ## **Requirements** ### **Core Competencies** - Strong communication skills in cross-functional and multicultural environments. - Solid analytical and problem-solving capabilities with a data-driven mindset. - Self-motivated and able to work independently with minimal supervision. - Scientifically curious with a continuous improvement mindset. - Proficiency in Design of Experiments (DOE) and statistical analysis tools. - Familiarity with Process Analytical Technology (PAT) and monitoring tools. ### **Technical & Educational Background** - Advanced degree in Biological Sciences, Biotechnology, Chemical Engineering, Chemistry, or related field. - Hands-on experience in biopharmaceutical laboratory environments, with demonstrated ability to independently design and execute studies. - For upstream specialization: - Experience in mammalian cell culture (seed train to bioreactor systems) - Familiarity with relevant analytical techniques - Strong understanding of process parameters and their interactions in upstream processes. - Experience with scale-down model development and/or qualification is highly desirable. - Familiarity with HSE, GLP, and basic cGMP requirements in biopharmaceutical environments. # Pursue *progress*, discover *extraordinary* Better is out there. 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