Process Development Joint Lab (PDJL) between Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR) and Advanced Cell Therapy and Research Institute Singapore (ACTRIS) aims to advance pre-GMP process and analytical development of cell therapy assets to support seamless transition towards GMP manufacturing. The PDJL will work closely with industry solution providers and in partnership with ACTRIS collaboratively support and advance development of novel cell therapy assets from local academia, national healthcare groups and biotech companies with the ultimate aim of translating them into GMP-compliant workflows for clinical-scale manufacturing.
We are looking for experienced Analytical Development Scientist with GMP, GLP and CMC experience to join this exciting translational fronting initiative to support with Process and Analytical Development for advancing cell therapy modalities. Selected candidates will support with project management, technology transfer activities and will be actively involved in planning and execution of analytical development studies in order to establish fit-for-purpose release assay methods for tech transfer to GMP manufacturing. Roles and responsibilities of candidates will include but not limited to the following:
· Technology Transfer of cell therapy pipelines (CAR-T, TCR-T, NK, ??-T, TILs, iPSC-derived cells) from asset developers to PDJL and subsequent transfer of established methods and SOPs to GMP manufacturing team
· Develop and optimize standardized assay methods for evaluating critical quality attributes of manufactured cells.
o Develop and optimize multi-parameter flow cytometry for phenotyping and characterizing cell populations
o Develop and optimize vector copy number determination using droplet digital PCR or quantitative real-time PCR.
o Develop and optimize functional and potency measurement of cells such as multiplex cytokine secretion assay, ELISA assay and cytotoxic cell killing assay.
o Support with further characterization of cells where required (serial killing assay, proteomic, transcriptomic, metabolomic analysis)
· Support with process related investigations and root cause analysis for issues arising during GMP manufacturing runs at CMO and support with necessary follow-up studies.
· Support Project management activities to ensure efficient and timely execution of activities, meticulous documentation of studies in GLP compliant manner and routine communication to update GMP partners and CT asset owners
· Perform data analysis, prepare technical reports, establish standard assay methodology for tech transfer to GMP team
· Training of GMP personal or QC personal on analytical assays
· Provide scientific guidance to Associate Scientists
· Perform other related duties incidental to the work described therein.
Job Requirements
· PhD in Immunology, LifeSciences, Biomanufacturing or in a relevant Science field or equivalent BioEngineering or Biotechnology field.
· Candidates with BSc and relevant industry experience will be considered as well.
· Industry or relevant experience in cell therapy related analytical assay development.
· Practical experience with performing analytical assays such as viability measurement, multi-parameter flow cytometry, ELISA, multiplex cytokine assays, vector copy number determination, real-time quantitative PCR, cytotoxicity cell killing assay (flow-cytometry based, Xcelligence real-time analyzer, Incucyte® live-cell analyzer)
· Technical knowledge in cell therapy related Quality control, GMP requirements, GLP compliance, method transfer, USP/ICH compliant assay development would be an advantage.
· Familiarity with utilization of analytical softwares (FlowJo?, MACSQuantify?, xCelligence RTCA, xPONENT®, software) and statistical softwares (JMP, MiniTab, GraphPad)
· Possess interpersonal communication skills with excellent written and oral communications.
· Demonstrate excellent quantitative, analytical, troubleshooting, time-management and organizational skills
· Strong team player who is independent, highly motivated and work collaboratively in an interdisciplinary team and diverse workforce
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
