Senior / Materials and Analytical Scientist

**Site Name**: Singapore - Jurong
**Posted Date**: Feb 13 2025
**_ Purpose_**:
Provide materials science and analytical expertise on drug substances and excipients used in small molecule and vaccines manufacturing at Global Supply Chain (GSC) sites on business-prioritized projects, established and new product introduction, covering a diverse range of services including technical leadership, materials risk assessments, analytical expertise and data interpretation as well as expert training.

**_Key Responsibilities_**:

- Provide physical characterization for a range of API as part of continued process verification and influence the optimization of primary and secondary manufacturing processes to improve right first-time performance, product quality, robustness, cost savings, manufacturability etc. in line with GMP requirements.
- Build understanding of the relationship between API manufacturing processes (e.g. primary unit operations like crystallization, filtration and drying) and API physical properties, supporting process troubleshooting/ change as required and assessing their potential impact on API physical properties and secondary drug product through materials risk assessments.
- Review and improve physical properties analytical methods, procedures and standards in accordance with pharmacopeial requirements or other analytical technical standards, lead/ support analytical method technology transfers, including method troubleshooting and optimization, ensuring analytical method robustness during the product lifecycle.
- Provide technical advice to internal/ external customers on physical properties techniques, including generation of data and its interpretation in comparability studies of drug substance (API) and excipients to support material and process changes/ improvements as well as root cause analysis in deviations/ investigations to ensure security of supply.
- Lead/ support key analytical activities, including analytical method transfers, optimization and troubleshooting, characterization as well as analytical equipment set-up, to support process development/ improvement for new vaccines products and intermediates.
- Qualification and lifecycle maintenance (including preventive maintenance/ calibration and performance verification checks) of physical properties and other analytical equipment to appropriate analytical technical standards, aligned with GMP and data management principles with mitigation of data integrity risks.
- Ensure proper and complete documentation on work and method procedures (standard operating procedures, work instructions) and data for all analysis carried out (includes laboratory notebooks, technical memos, analytical raw data, risk assessments, etc) in compliance with GMP and GLP requirements, ensuring traceability and retrievability of archived data.
- Supervise and train laboratory technicians, interns and junior scientists to ensure good and safe work practices, quality and reliability of data and to support personnel development and capability build.

**_ Skills, Knowledge and Experience_**:

- At least a degree in Pharmacy, Material Science, Chemistry, Pharmaceutical Sciences, Biochemistry/ Biotechnology, Biomedical Engineering or equivalent.
- Experience in a GMP laboratory environment in the pharmaceutical industry or equivalent.
- Hands-on experience, and skilled in execution, optimization and trouble-shooting in any of the following analytical techniques is preferred: Particle sizing by laser diffraction, microscopy and imaging, powder flow characterization, thermal analysis (DSC, TGA), X-ray powder diffraction (XRD), chromatographic techniques (Ultra-performance liquid chromatography, size-exclusion chromatography with multi-angle light scattering, gas chromatography), fluorescence-based quantification (Qubit), dynamic light scattering and interaction analysis (dynamic light scattering, particle size by photon correlation spectroscopy, Octet), ELISA immunoassay, chemical analysis (lipid/ polysaccharide content by spectrophotometry, Lowry assay) and molecular biology techniques (polymerase chain reaction).
- Basic knowledge of API, drug product and/ or vaccines manufacturing processes.
- Enjoy working in a laboratory environment and thrive in activities and tasks related to analytical troubleshooting, problem solving and root cause analysis under time pressure.
- Excellent inter-personal communication skills, proactive with leadership skills, data-driven decision making and stakeholder management skills with the ability to work in cross-functional teams (across R&D and Quality).
- Possess a continuous improvement mindset and be able to lead improvement initiatives.

Li-GSK

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and