Job Description
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 industry experienced Process and 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 cell therapy process and analytical development studies in order to establish GMP-ready standard operating protocols and 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
· Gap assessment to identify studies required for optimizing unit operations and establishing integrated manufacturing workflows.
· Plan and execute studies for optimization and development of standardized assay methods for evaluating critical quality attributes of manufactured cells.
· Establish and execute scale-down DoE studies to optimize critical process parameters for manufacturing unit operations.
· Establish standardized manufacturing workflows using modular manufacturing platforms or automated manufacturing platforms as well as scale-up of process where required.
· Support with process related investigations and perform root cause analysis for issues arising during GMP manufacturing runs at CMO and peform 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 operating protocols and assay methodology for tech transfer to GMP team.
· Training of GMP personal on manufacturing workflows and QC personal on assays
· Provide scientific guidance to Associate Scientists
· Perform other related duties incidental to the work described therein.
Job Requirements
· PhD in Immunology, Life Sciences, 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 manufacturing and/or cell therapy related analytical assay development.
· Prior experience in handling and management of BSL-2 viral pathogens (retrovirus, lentivirus, Sendai virus)
· Prior experience in handling immune cell cultures such as TCR-T, CAR-T, NK, gamma-delta-T cells
· Practical experience with biomanufacturing platforms such as G-REX, Miltenyi CliniMacs Prodigy, Lonza Cocoon, Wave or Stirred Tank bioreactors.
· Technical knowledge in cell therapy related CMC and GMP requirements, GLP compliance, FMEA analysis, process technology transfer and/or ICH compliant assay development
· Experience in Flow cytometry, ELISA assays, xCelligence real-time cell analyzer, multiplex cytokine assays
· Familiarity with DoE methodologies
· 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.
