Senior Associate Scientist, Analytical Development (Contract)

Allogene Therapeutics; South San Francisco (CA); On-site; USD 62,000 - 69,000; Full time

Job summary

Allogene Therapeutics, Inc. in South San Francisco, CA is seeking a scientist to help develop and characterize clinical-scale manufacturing of Allogene CAR T products.

You will support flow cytometry-based and cell-based analytical methods for characterization, release and stability testing, and collaborate with the CAR T Research and Process Development groups. This 1-year contract role involves GMP manufacturing support, data integrity, and cross-functional teamwork to drive regulatory-ready

Qualifications

• Degree in immunology, cell biology or related field; lab experience with analytical methods for cell therapies.
• Experience with flow cytometry-based characterization, release, and stability testing.
• Familiarity with regulatory guidance documents and GMP environments.

Responsibilities

• Contribute to flow cytometry and cell-based assay development for CAR T analytics.
• Support qualification of in-process and release methods and tech transfer activities.
• Collaborate with CAR T Research and Process Development teams and document results.

Skills

Flow cytometry

Cell-based assays

Data analysis

FlowJo

Spotfire

R

cGMP familiarity

Independent work

Interpersonal skills

Written communication

Education

Bachelor’s degree in immunology or cell biology

Master’s degree in immunology or cell biology

Tools

FlowJo

Spotfire

R

Job description

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

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™). 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.

Responsibilities include, but are not limited to:

• 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.
• This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.

We offer a chance to work with talented people in a collaborative environment. 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.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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