Bioanalytics Manager

2 weeks ago

Singapore VECTURA FERTIN PHARMA LABORATORIES PTE. LTD. Full time

**The Role**

1) Lead, develop and motivate the Bioanalytics group, which is a skilled team focusing on:
i) the quantitative measurement of compounds or chemicals from biological samples, or from formulations
ii) development and validation of methods for detection of single or complex chemical mixtures in various matrices.

Managerial duties include objective setting and performance evaluation, providing technical and people leadership, developing learning & training plans to facilitate individual's development, and providing regular feedback.

2) Oversee the overall activities in the Bioanalytics laboratories to ensure SOP / technical guides and training are available and for the team members to perform their day to day tasks, and that the test results are reported within timelines agreed upon with the study requirements and/or stakeholders. To ensure the methods, equipment, systems, and workflows are fit for purpose, up to date and efficient.

3) Keep track with the technological advancement in the field, assess, adopt and provide expertise for developing and implementing new / innovative techniques, assays, methods, and 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.

4) 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.

5) Ensure the day to day laboratory operation is smooth and efficient, devise and implement continuous improvement projects to keep the laboratory operation and systems to the best practices.

6) 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.

**The Talent**:
1) 5 years relevant professional experience with technical and scientific knowledge with focus on analytical and bioanalytical method development, validation and laboratory operations would be strongly preferred. Previous experience with a CRO, R&D unit within pharmaceutical or healthcare industries, or research organizations is preferred.

2) In depth knowledge preferably with hands-on experience on a broad range of analytical and bioanalytical platforms and work flows in toxicology studies and life science research, i.e. LC/GC, LC-MS/MS, FACS, IHC, clinical chemistry, hematology, molecular biology and other characterization tools for chemical and biological entities and systems.

3) Good understanding on regulatory guidelines such as FDA, ICH, OECD GLP and TGs related to in vivo toxicology study and method validation is preferred

4) Comfortable with managing R&D team and project

5) Excellent communication and influencing skills

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