BioSpace · 5 days ago

Principal Research Associate, Process Development

Santa Monica, CA

Full-time

Onsite

Mid Level

$85K/yr - $100K/yr

3+ years exp

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Comp. & Benefits

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Responsibilities

Participate in the design, execution and support of laboratory studies for development, optimization, and manufacture of genome engineered TCR T cell products using non-viral genome editing tools.

Execute and support analytical methods for process development studies.

Support experimental designs, planning, execution, analysis, and reporting results of process development studies.

Participate in a cross-functional team to transfer technology to cGMP manufacturing partners.

Support, author, and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations.

Collaborate with internal and external partners to evaluate and implement new process technologies to develop next generation processes.

Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.

Work effectively in a team environment to meet project timeline and objectives.

Perform other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Genome EngineeringT CellFlow CytometryAnalytical MethodsBiological ProductsMicrosoft ExcelStatistical AnalysisUS/EU Regulatory RequirementsCGMPsExperimental DesignProblem-SolvingCritical ThinkingAnalytical SkillsProduction ProcessesPrimary CellsT Cells

Required

8+ years with High School; 4+ years with BS/BA; 2+ years with MS/MA in Immunology, Cell Biology, Molecular biology, Bioengineering; 2+ years with Eng Degree

At least 3 years of relevant experience in developing production processes for genome engineered primary cells (required) including T cells (highly preferred)

A minimum of two (2) years practical experience with Flow Cytometry

Hands-on experience performing analytical methods typically used in the manufacture and characterization of biological products

Proficiency with Microsoft Excel or statistical analysis software (JMP, Minitab, Prism, etc.) for analyzing and presenting data

Working understanding of US/EU regulatory requirements and working knowledge of cGMPs

Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning

Ability to design and execute experiments with minimal technical supervision