Bioanalytics Manager (Pharma)
Our client is GLP-compliant and AAALAC accredited, preclinical CRO based in Singapore. We are currently looking for a Bioanalytics Manager to support the operations
- Location: Central
- 5 Days Work
- Up to $9000 depending on experience
- Immediate Vacancy !!
Purpose of the role:
- In charge of Bioanalytics group with broad technical portfolio of clinical chemistry, hematology, cell / molecular biology assays (i.e. FACS, IHC), biomarker quantitation, chromatography (i.e. GC, LC), and mass spectrometry (i.e. LC-MS/MS, GC-MS/MS), to build functional capability and capacity for efficient execution of in vivo toxicology and studies at the center, and ensure scientific and technical rigor in the responsible areas to support company's science and innovation pipelines.
- Lead, motivate and develop the teams 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).
- Plan, direct and manage the operations for the Bioanalytics laboratories:
- resource, budget, timelines and risks;
- update and maintenance of equipment, workflows, and laboratory information systems; and
- development and implementation of new assays, test methods, equipment, workflows, and systems.
- Lead, develop and motivate the Bioanalytics group (5-8 people), including objective setting and performance evaluation, providing technical and people leadership, developing learning & training plan to facilitate individual's development, providing regular feedback.
- Oversee the overall activities in the Bioanalytics laboratories to ensure SOP / technical guides and training are available and adequate for the technician to perform their day to day tasks, and the test results are turned around within the time in agreement with the study requirements and/or stakeholders. 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, 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 up 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.
- Minimal 5 years relevant professional experience with technical and scientific knowledge with focus on analytical 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 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.
- Good understanding on regulatory guidelines such as FDA, ICH, OECD GLP and TGs related to in vivo toxicology study and method validation is ideal
- Experience on managing R&D team and project
- Excellent communication and influencing skills
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.email@example.com
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579