Senior Associate Scientist, Analytical Development (Contract)

About the role

Allogene is seeking a highly determined, results-oriented, self-starter who demonstrates personal accountability for outcomes and is motivated by increasing levels of responsibility, to join a dynamic team responsible for successful development and characterization of clinical-scale manufacturing of Allogeneic Chimeric Antigen Receptor T-cell therapies (Allo CAR T™).

Responsibilities

• Actively contributes to successful and efficient execution of robust, state-of-the-art multicolor flow cytometry methods, cell-based potency assays and molecular assays for the characterization of CAR T manufacturing processes and products
• Provide analytical support for the development and execution of Process Characterization and BLA-enabling activities, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.
• Contribute to project technical teams to ensure effective communication at all levels. Collaborate effectively to ensure productive interactions with all stakeholder groups.
• Demonstrate strong accountability, organizational and interpersonal skills, and apply sound scientific and technical experience.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings.
• Present data/ strategy to scientists and management internally.

Position Requirements & Experience

• Bachelor’s degree or master’s degree in immunology, cell biology or related field is required (or relevant experience).
• Laboratory experience in a variety of analytical methods for the characterization and release of cell-based therapies, include, but not limited to: multi-parametric flow cytometry-based assays for characterization/ release/ stability testing, cell-based cytotoxicity assays, cell-based proliferation assays and cytokine measurements.
• Hands-on expertise in handling and processing of primary peripheral blood mononuclear cells or cell culture and analysis of T cell subsets and subpopulations (desired).
• Proficiency in data analysis and interpretation using FlowJo would be advantageous.
• Proficiency in Spotfire or R a plus
• Familiarity with cGMPs and relevant Regulatory Guidance documents.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.

Pay

The expected hourly salary range for this role is $45 to $50 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.