Senior Scientist - Cell Therapy Process Development
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Location
California
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Sector:
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Salary:
Negotiable
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Contact:
Hanaa Sammra
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Contact email:
Hanaa.Samrra@voltinternational.co.uk
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Job ref:
BBBH1115_1627047325
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Published:
meer dan 2 jaar geleden
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Expiry date:
2021-08-24
Responsibilities
*Optimize process and procedures to assess quality of product and effectiveness of manufacturing
*Supervising clinical materials based on cGMP standards
*Meeting project deadlines
*Supporting senior management with projects
*Oversee and execute development of new cell therapy processes and procedures to produce products in support of IND-enabling studies and clinical studies in humans
*Supporting the writing of the investigational new drug and chemistry manufacturing control
Qualifications:
*Bachelor's degree or Master's degree in Biological Sciences
*10+ years of experience within the biopharmaceutical industry / Ph.D. with 5+ years of biopharmaceutical industry experience
*Experience in cell therapy process development at clinical stage
*Ability to design and execute large scale process development engineering optimization experiments
*Awareness of cGMP requirements and working within a regulated environment
*Ideal development and technology transfer of cell therapy products
*Viral and non-viral transduction principles and procedures
*Knowledge of Design of Experiment (DOE) and Quality by Design (QBD)
*Exceptional communication and written skills and ability to multitask within a fast-paced environment