Role Summary
- Analytical Chemist in a team with a broad technical portfolio of technics such as chromatography (i.e. GC, LC0, and mass spectrometry (i.e. LC-MS/MS, GC-MS/MS). The role will aim at building functional capability and capacity for efficient execution of in vivo toxicology and studies at the facility. In addition, this role will ensure scientific and technical rigor in the responsible areas to support Company's science and innovation pipelines
- This role will be part of a team where he/she will have to work jointly with operators having different levels of expertise. Communication, proactiveness, and self-management will be essential in order to deliver functional execution of in vivo studies on time and on budget whilst ensuring compliance with pertinent guidelines and scientific standards (i.e. OECD GLP, ISO, AVA, AAALAC, OECD TGs and USFDA)
- This role will also have to (1) plan resources and timelines; (2) update and maintain equipments, workflows, and laboratory information systems; and (3) develop and implement new assays, test methods, equipment workflows and systems
Responsibilities
- Lead the organization's effort on test method development / optimization and validation focusing on chromatographic systems (i.e GC, LC) and mass spectrum (i.e LC-MS/MS, GC-MS/MS) for the identification and quantification of chemical constituents and metabolic biomarkers in complex matters
- Provide technical leadership to the Bioanalytics department in the relevant technical domain; conduct training to the junior analysts and new hires; provide first-line technical support to day-to-day smooth quality testing. Act as a study director for GLP studies in the Bioanalytics department. Ensure the methods, equipment, systems and workflows are fit for purpose, up-to-date and efficient
- Keep track with the technological advancement in the field, assess, adopt and provide expertise for developing and implementing new / innovative techniques, assays, methods, capabilities that will enable / accelerate Company's scientific project portfolio execution in particular for scientific substantiation of RRP products and exploration of adjacent therapeutic areas
- Represent the functions to coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, global counterparts) on the planning, resourcing, execution, data analysis and reporting of in vivo (and ex vivo, in vitro) pre-clinical studies within R&D. Foster a culture of collaboration and enable frequent technical exchange across the network.
- Ensure the day-to-day laboratory operation is smooth and efficient, devise and implement continuous improvement projects to keep up the laboratory operation and systems to the best practices
- Participate in establishing and maintaining an adequate, current and effective QMS system and assume ownership roles for the business area, systems, equipment and SOPs when applicable. Support quality / compliance inspections and audits conducted by both internal and external parties
- Back-up to the department manager to review and approve test results, and assist on study planning for the Bioanalytics department in work flow optimization, resourcing, procurement etc
Requirements
- Bachelor's degree in scientific discipline
- PhD in Chemistry, Life Sciences or related technical/scientific discipline is preferred
- Minimal 5 years' relevant experience with technical and scientific knowledge with focus on analytica and bioanalytical method development, validation and laboratory operations, with a CRO, R&D unit within pharmaceutical or healthcare industries, or translational academic research organizations
- In-depth knowledge preferably with hands-on experience on broad range of analytical and bioanlytical platforms and work flows in toxicology studies and life science research, i.e. LC/GC, LC-MS/MS, and other characterization tools for chemical entities
- Good understanding of regulatory guidelines such as FDA, ICH, OECD GLP and TGs related to in vivo toxicology study and method validation is preferred
- Excellent communication and influencing skills
