Posted on Apr 5, 2021 by Lonza
Experienced in development and optimization of cell culture processes for the production of cell and gene therapy products. The successful candidate should have experience with primary cell and tissue isolation techniques, maintenance, expansion, and differentiation of stem cells including pluripotent stem cells, Mesenchymal Stem cells, in vitro culture of T and NK cells and/or primary cells derived from human tissue, in vitro culture of adherent and suspension cell lines, gene modification and transfection/transduction techniques, downstream and fill/finish processing. She/he should be able to assist both technical scientists and management in the design and execution of new or unique cell-based projects; be able to assist with tech transfer of processes to manufacturing and design of investigation studies for Manufacturing Sciences and Technology (MSAT) and manufacturing team; be able to train and mentor other technical scientists and manufacturing personnel in the development and/or execution of developed process plans; analyze bioprocessing data to monitor, optimize and determine limits of process performance. She/he should be able to present data and clearly communicate the results of process development studies with the clients. Experience with Design of Experiment (DOE) and statistical analysis is preferred.
Responsible for successful development and execution of state-of-the-art manufacturing processes for current Good Manufacturing Practices (cGMP) manufacturing within the Cell Therapy Development matrix.
Interact with new or existing Cell Therapy clients to document and transfer new processes to Lonza sites and communicate and present the work in meetings.
Contribute and support scientific or engineering expertise toward the design and development of new process ideas that support client product concepts.
Design and review of experiments of cell process optimization, scale up and cryopreservation, trouble shoot the problems.
Oversee the initial technical training of specific Process Development protocols to Cell Therapy Manufacturing Teams.
Establish and maintain a good working relationship within the operations department and other departments such as Research and Technology (R&T), Quality Control (QC), Quality Assurance (QA) and Project Management (PM).
Lead, review and/or train/assist in writing and revising technical documents including laboratory SOPs, protocols, reports and batch records.
Support Research and Technology (R&T) projects by providing constructive technical feedback and improving new processes as they are being transferred into Cell Therapy Development prior to offering to clients.
Perform other duties as assigned.
PhD in Life Sciences with focus on Stem cell Biology, Immuno-oncology, Bioprocessing or Bioengineering with intermediate years of related experience; MS degree in Life Sciences field with advanced years; BS degree with extensive years of related manufacturing or process development experience in biotech industry.
Mammalian cell culture experience, and specifically experience with stem cells, immune cells or human primary cells.
Preference to familiarity with a GMP environment.
Understanding cell-based assays including, but not limited to, morphological assessment, cell proliferation, functional differentiation, cytotoxicity, detection of marker expression (ICC), Flow Cytometry, qPCR and ELISAs.
Experience with DOE and statistical analysis is preferred
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