Associate Scientist, Analytical Operations

职位描述

Department: Analytical Development

Location: Santa Monica, CA

Position: Associate Scientist

Analytical Development, Process Development

Analytical Development is looking for a talented and highly motivated Associate Scientist (AS) with a background in molecular biology, specifically ddPCR or qPCR-based assays, to join a team focusing on the characterization and/or release assay development for drug substance (LVV/RVV) and drug product for T cell therapies. The incumbent will be responsible for executing ddPCR based analytical method development with minimal supervision, generate, analyze, interpret, and present experimental data, and carefully document resultant information in ELNs. Should be able to write SOP, protocols, and reports. This is a Lab based role which requires to be onsite.

Responsibilities and Duties

• With minimal supervision, execute and document ddPCR/qPCR method development (GC, VCN, IFU and impurities) activities in support of process development, product release and stability, and product characterization of drug substance (vector) and T cell drug products.

• Perform qualification studies for Analytical methods per established guidance and ICH guidelines.

• Maintain accurate documentation of experiments in ELN and reports.

• Data analysis (JMP), interpret the results and presentation at the group and cross functional meetings.

• Work closely with QC during knowledge, method transfer and co-qualification.

• Contribute to technical documents (e.g., development reports, SOPs, and technical reports).

• Maintain, calibrate and operate analytical equipment and instruments.

• Ensure that departmental areas are maintained per 5S guidelines.

Basic Requirements

• MA/MS/MBA with 3+ years of relevant experience; OR

• BA/BS with 5+ years of relevant experience

Preferred Qualifications

• Background in immunology, molecular biology, cell biology.

• Relevant ddPCR/qPCR assay development or assay execution experience is a must. Experience with molecular biology techniques (transduction, titer, DNA/RNA extractions, cDNA synthesis, Primer designs, PCR/ddPCR) is a must.

• Knowledge of T cell biology and immune cell therapy (e.g., viral vectors, CAR T functional assays) is strongly desired.

• Experience with Mammalian cell culture.

• Prior industrial experience is a plus.

• Proven ability to work in a fast-paced environment, meet deadlines, prioritize work on multiple projects.

• Excellent skills in Microsoft Office, data analysis software (e.g. JMP, Graphpad Prism, Geneious, Snapgene, SoftMax Pro), and other applications.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Overall understanding of drug development process and its impact on projects, goal and timelines is preferred.

• Ability to work independently and as part of a team

• Occasional Travel

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