Role Summary
This role will be responsible to establish and execute in vitro toxicology and pharmacology studies. This will include regulatory in vitro toxicological assays such as microbial mutagenicity assays, as well as cell-based cytotoxicity and genotoxicity assays, in accordance with the OECD GLP requirements.
In the team, this role will also be responsible for providing downstream cell and biochemical assay development, validation, and analysis services to support organization's in vivo study execution, which includes a battery of clinical pathology assays, flow cytometry, and ELISA assays.
This role will also lead the organizational effort in developing and implementing state-of-the art organotypic cultures and new in vitro capabilities to advance the regulatory-compliant ready research capability in line with the 3Rs principle of animal research adopted by the organization.
Responsibilities
- Responsible for establishing, maintaining and improving the technical expertise in the domain of in vitro toxicology and genotoxicology, keeping up to scientific and regulatory advancement in the field. This may include, but not limited to microbial mutagenesis assay (Ames), cell-based viability assays (neutral red uptake) or mutagenesis assays (mouse lymphoma assay, micronucleus assay)
- Act as Study Director for the in vitro toxicology and pharmacology studies executed at the facility, responsible for the overall scientific conduct of the study, from the conceptualization to the closure. Study Director plans, manages and reports the studies in accordance with pertinent regulatory guidelines (i.e. OECD GLP Principles and Test Guidelines) and to customer's satisfaction
- Coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, global counterparts, external clients) on the planning, resourcing, execution, data analysis and reporting of relevant study phase (i.e. clinical pathology, flow cytometry and biochemical assays) for the in vivo pre-clinical studies
- 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 and/or will meet external client needs
- Plan and conduct studies using project management tools within the timelines and budget, anticipate variations and provide information about changes on a timely basis. May have client facing opportunities
- Support quality/compliance inspections and audits conducted by both internal and external parties
Requirement
- PhD in Chemistry, Life Sciences, Biology or related technical/scientific discipline
- Minimum 5 years relevant professional experience with in-depth scientific knowledge focusing on in vitro research and/or toxicology studies with a CRO, R&D unit within life science industry, or translational academic research organizations, preferably in a regulated environment
- In-depth knowledge preferably with hands-on experience on in vitro research and/or pre-clinical in vitro toxicology research
- Independent ability to develop/optimize/validate cell-based and/or microbiological assays.
- Understanding on regulatory guidelines such as FDA, ICH, OECD GLP and TGs related to in vitro toxicology study and genotoxicity, and quality management is preferred
- Experience with leading R&D project
- Self-starter and highly motivated individual with excellent communication and influencing skills
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