Responsible for successful development and execution of state-of-the-art manufacturing processes for 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
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
Oversee the initial technical training of specific Process Development protocols to Cell Therapy Manufacturing Teams.
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.
A Masters with at least 2 years of experience or Bachelors with 4 or more years of experience, preferably in a life sciences related field.
Mammalian cell culture experience with strong aseptic technique. Preferably experience with stem cells, immune cells or human-sourced primary cells, strong aseptic technique.
Demonstrated Experience with analytical methods for cellular analysis, such as qPCR, FACS analysis and ELISA
Strong technical writing skills.
Experience with current Good Manufacturing Practice (GMP), preferably working in a cGMP environment
Hands-on experience with single-use and scalable systems, such as multi-layered flasks and/or bioreactor systems
Experience with statistical analysis of data (Excel, JMP, Prism, etc.).
Experience with optimization and qualification of quantitative experimental design and statistical methods.
Computer software skills including Microsoft Office, Document management systems; accurate record keeping; ability to manage multiple projects; time management skills.
Diplomacy; negotiation skills; written and oral communication skills; independent work skills; strong work ethic.
