Staff Scientist Process Development-CRB

Work unit scientist who with minimal supervision leads the development, scale-up and optimization of novel/new biotherapeutics in preparation for cGMP compliant manufacturing operations. Drafts technical documentation such as study reports, standard operating procedures (SOPs), manufacturing batch records and associated records to support transition of biotherapeutics into clinical production and product validation for FDA-regulated, cGMP compliant manufacturing operations. 

Responsibilities will include design and execution of studies to support process optimization for clinical translation of novel biotherapeutics. Optimization of process steps to target process scale for improvement of existing methods or implementation of novel technology of proven validity. Analysis, organization, and presentation of data in a clear and concise manner. Creation of batch documentation, maintenance of laboratory notebooks and preparation of protocols and reports in a compliant manner. Provides direction to junior scientists and process development technologists.

Development of release test methods, maturation of research analytical methodology into development and cGMP, analytical method technology transfer to and from our facilities and/or contract vendors. Plans and executes laboratory studies, performs experimental data analyses and carefully documents resultant information. Provides guidance and training in technical writing and project tracking for junior staff. Trains manufacturing personnel in final product manufacturing processes.

PhD in biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution with 5 plus years of relevant industry/academia experience in biotherapeutics. 

Self-motivated, highly organized, efficient, and able to work independently exercising strong decision-making skills. Excellent written and verbal communication skills are necessary. Capable of reproducing a reference method using available procedures without supervision. Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures. Experience with data collection, organization, analysis and delivery of information.

Preference given to candidates with experience in immune effector cell biomanufacturing. 

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