Process Development Specialist
Company: Clade Therapeutics
Location: Cambridge
Posted on: June 19, 2022
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Job Description:
Process Development SpecialistAbout Clade Therapeutics Clade
Therapeutics is a well-funded, early-stage cell therapy company
developing novel cell-based medicines for the treatment of cancer
and other devastating diseases. The Company, located in Kendall
Square, was founded by an exceptional group of academic leaders and
successful bioentrepreneurs. Clade works at the convergence of stem
cell biology, immunology, regenerative medicine, and gene editing
to create the next-generation of stem cell-derived medicines.We are
passionate about delivering on the promise of cellular therapy,
shaping the future of cellular medicine, and delivering new
therapies to millions of patients.Position SummaryThe Process
Development Specialist will interface with members of the R&D
team to develop processes for producing iPSCs and differentiating
iPSCs into cell therapies including T-cells, B cells and other
immune cells. This position requires experience in developing
processes for production of cell therapies in bioreactors, cell
harvest and cryopreservation, and implementation of those processes
in a cGMP environment. The Process Development Specialist will
establish scale-down bioreactor models and analytics to support
high-throughput media and bioreactor optimization studies. The
Process Development Specialist will also interface with internal
and external GMP manufacturing teams to support tech transfer and
provide technical support for process changes and investigations.If
interested and qualified, please include Requisition # 2022-62 in
the subject line when emailing resume to:
careers@cladetx.comResponsibilities --- Interface with the R&D
teams to provide input on selection of media, reagents and culture
methods for early-stage evaluation of differentiation methods and
cell line candidates. --- Create process development plan to
support manufacturing for IND-enabling studies, human clinical
trials, and process scale-up for late-stage clinical trials and
commercial manufacturing. Identify and evaluate technologies,
methodologies, and equipment applicable to PSC production,
differentiation, harvest and cryopreservation. --- Establish
scale-down bioreactor models and analytics to support media
optimization and bioreactor optimization studies. Utilize DOE and
other statistical methods to evaluate design space of manufacturing
operations, identify Key Process Parameters, and optimize
manufacturing processes. --- Interface with Analytical Development
to identify key assays required to support early-stage PD
activities. Provide material to AD and Quality Control to support
assay development and qualification activities. --- Interface with
internal and external GMP manufacturing teams to support tech
transfer and cell therapy manufacturing activities including
support for process changes, troubleshooting and investigations.
--- Interface with the Nonclinical Studies team to provide
materials for in vivo studies to demonstrate POC and evaluate key
process decisions, selection of Drug Product formulation, and
evaluation of cell therapy delivery methods.Qualifications --- BS
in engineering, biological sciences or other relevant discipline
with 5+ years of relevant industry experience required or MS/PhD
with equivalent experience --- Experience in upstream process
development and GMP manufacturing of biologics is required,
experience in cell therapy manufacturing is a plus --- Experience
in optimization of bioreactors and cell culture media with
experience in Design of Experiment (DoE) is highly desirable ---
Experience in analysis of cells/media including cell counting,
media analysis and flow cytometry is also desirable --- Knowledge
of Current Good Manufacturing Practices (cGMP) and the impact of
process design and raw material selection on GMP compliance and
regulatory risksCorporate Values
Keywords: Clade Therapeutics, Cambridge , Process Development Specialist, Other , Cambridge, Massachusetts
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