Senior Associate Scientist, Analytical Development (Contract)

Allogene Therapeutics•South San Francisco, CA

2d•Onsite

About The Position

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™). The successful candidate will help to support appropriate flow cytometry-based and/or cell-based analytical methods for the characterization, release and stability testing of CAR T products. This position will also contribute to the development of novel technologies and approaches to meet future CAR T analytical needs and work in close collaboration with key stakeholders, including the CAR T Research and Process Development groups.

Requirements

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.
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.

Nice To Haves

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

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.