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Job Title:Senior Scientist-
Assay Development (US)

Responsible to: GMP- Manufacturing Manager

Role

To work under the direction of the GMP-Manufacturing Manager, and alongside
the Sr. Scientist for process development in a tissue culture environment to
support the manufacture of patient specific products for T cell immunotherapy.
The Assay Development Scientist will work with autologous and allogeneic human cell
products in accordance with GLP regulations. This position will focus on the
development, improvement and validation of cell based QC assays as well as
supporting process changes by generating product and by completing analysis of
products generated under the direction of the Process development technician. With
this position, individuals can make an important contribution to advancing this
exciting new field of patient specific cellular therapeutics.

A willingness to work flexible hours when required is essential. This
position entails possible night and weekend work.

This position is based in Houston, TX.

Responsibilities

Set up and execution
of cell characterization assays such as proliferation assays, intracellular
cytokine staining, ELISPOT assays and cytotoxicity assays.

Phenotyping by multicolor flow cytometry.

Flow cytometry data
analysis of manufacturing data from CMO

Optimization and
validation of counting and phenotyping by flow cytometry.

Perform QC assays on
products generated alongside the process development scientist.

Development and
optimization of novel assays for T cell characterization

Execution of specific
manufacturing processes in collaboration with the process development scientist
to generate patient specificcellular therapeutics as required.

Perform other related
procedures including sample preparation, shipping, media preparation, ordering
procedure, logistics activities.


Accurate documentation according to GLP e.g. filling out batch records,
writing reports


Participate
in the implementation of standard operating procedures and policies for the
laboratory.

Execute laboratory
research experiments in line with DOE and QbD principles with attention to
details and limited oversight.

Collects, compiles and
analyzes research data.

Works under minimal
supervision. Needs to attend to details and be able to work independently after
the initial training.

Documents and
interprets results of experiments and reports to supervisor

Oversees the
maintenance of lab equipment and environment, orders laboratory supplies and
equipment.

Performs other job
related duties as assigned.

Education
and Experience

A minimum of a Master’s degree with focus on biotechnology, bioprocessing,cell biology and/ or human cell culturing techniques (stem cells, primary cells and/or tissue culture)

Specific experience
working with T cells/ immunology would be highly beneficial

At least 4 years’ tissue or cell culture experience in an industrial or academic laboratory environment.

Flow cytometry
experience (sample preparation, cytometer operation and multi parameter
analysis) is essential to the role.

Experience in cell
characterization assay optimization is desirable

Good knowledge of
standard MS-Office products

Personal Attributes

Have an affinity with
GMP, GLP guidelines and like to work in a quality-oriented environment.

Experience with
standard cell biological assays and analytical procedures (ELISA, FACS, cell
counting, viability, sterility testing etc.) is a must.

A people-oriented team
player, independent thinker, accurate, precise and constructively critical.

About Cell Medica

Cell Medica is a cell therapy company engaged in the development, manufacture, marketing and distribution of cell-based products for immune reconstitution and cancer. The Company’s Cytovirâ„¢ product family for immune reconstitution targets the prevention and treatment of infections caused by latent viruses in immunosuppressed patients following allogeneic haematopoietic stem cell (bone marrow) transplant. In the field of cancer immunotherapy, Cell Medica’s Cytorexâ„¢ product family is targeting a range of cancers associated with the oncogenic Epstein Barr Virus(EBV). Cell Medica is based on London, United Kingdom, with facilities in Houston, Texas, USA, and Zurich, Switzerland. For more information, please visithttp://www.cellmedica.co.uk.


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