Senior Associate Scientist, Analytical Science (Contract)

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

Job summary

Allogene Therapeutics in South San Francisco, CA, seeks a motivated analytical scientist to advance clinical-scale manufacturing analytics for Allo CAR T therapies. You will develop and qualify analytical methods, support impurity testing, and contribute to GMP manufacturing documentation.

Responsibilities include collaboration with cross-functional teams, data interpretation, and presenting findings to scientists and management.

Qualifications

• Bachelor’s degree or master’s degree in immunology, molecular biology or related field is required.
• Experience with nucleic acid extraction, qPCR, ddPCR, western blot, and ELISA.
• Hands-on expertise in handling and processing mammalian cells.
• Familiarity with cGMPs and regulatory guidance documents is a plus.
• Excellent organizational skills and an ability to prioritize effectively to deliver results on time.
• Ability to work independently and as part of a team.
• Authorized to work in the U.S.
• 1-year contract opportunity with potential extension or contract-to-hire.

Responsibilities

• Participate in analytical method development and qualification, drug product characterization and impurity testing.
• Provide analytical support for Process Characterization and BLA-enabling activities, including qualification of in-process and release methods and tech transfer in GMP manufacturing.
• Collaborate with project teams to communicate effectively with stakeholders.
• Demonstrate strong accountability, organization and interpersonal skills.
• Ensure high-quality, timely documentation in electronic lab notebooks and technical reports for regulatory filings.
• Present data/strategy to scientists and management.

Skills

Analytical method development

qPCR

ddPCR

Western blot

ELISA

Mammalian cell handling

Data analysis

GMP knowledge

Regulatory guidance familiarity

Communication skills

Education

Immunology or molecular biology degree

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 analytical methods development and execution for CAR T products.

Responsibilities include, but are not limited to:

• Participate in analytical method development and qualification, drug product characterization and impurity testing
• 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 stakeholders
• 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, molecular biology or related field is required (or relevant experience)
• Laboratory experience in a variety of analytical methods, including but not limited to nucleic acid extraction, qPCR, ddPCR, western blot, and ELISA
• Hands-on expertise in handling and processing mammalian cells.
• Proficiency in data analysis and interpretation would be advantageous.
• Familiarity with cGMPs and relevant regulatory guidance documents is a plus
• 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 salary range for this role is $45-$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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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