Process Development Associate I/II - Oakland, United States - Bayside Solutions

Description

Process Development Associate

W2 Contract

Location: Berkeley, CA - Onsite Role

Job Summary:

Bayside Solutions has an exciting opportunity for a Process Development Associate to help support CAR-T process development and scale-up for our client in Berkeley, CA. This individual will help identify GAPS and will propose and evaluate process improvements. They will also draft SOPs, perform analysis of cell products, and share results with relevant groups. Additionally, they will support donor testing through donor whole blood screening via ddPCR as those products come in.

Duties and Responsibilities:

• Support donor screening to evaluate and source GMP leukoplakia from multiple vendors.
• Perform ddPCR on samples and prepare a summary of results to the donor selection team.
• Support cGMP-compatible CAR-T cell separation, cell enrichment, cell expansion, gene editing, final formulation, and related processes for scale-up
• Use engineering principles to leverage bench and pilot scale models for cell therapy manufacturing process performance characterization.
• Design and execute characterization studies and evaluate product impact of scale-up and raw material changes.
• Generate development reports, prepare SOPs, and batch record reviews.
• Author study designs and reports (i.e., electronic notebook submissions)
• Participate in cross-functional teams, working in a highly matrixed environment to advance preclinical programs.
• Support cell processes, including cell banking, cell expansion, and final formulation

Requirements and Qualifications:

• Bachelor's or Master's degree in Biology or a related field
• Minimum of 3 years of experience in pharma or biotech, preferably in process development, analytical development, or manufacturing operations
• Experience with molecular biology techniques, especially those directly related to ddPCR or qPCR (e.g., DNA extractions, PCR, column-based purifications)
• Experience with cell culture, cell-based assays, and a working knowledge of cell biology/immunology
• Excellent verbal and written communication skills; attention to detail is also a must

Desired Skills and Experience

Process Development, ddPCR, qPCR, cell culture, cell-based assays, CAR-T cell separation, cell enrichment, cell expansion, gene editing, formulation

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