Associate Scientist, Process & Product Development (Contract)

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.

Allogene is seeking a highly motivated Associate Scientist to support the development and characterization of clinical-scale manufacturing processes for Allogenes CART therapies.

About the role:

This individual will contribute to the development implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes and support successful tech transfer for GMP manufacturing and release. This position will also contribute to the development of novel technologies and approaches to meet future CART manufacturing needs.

Responsibilities:

• Actively contribute to development implementation characterization and successful execution of robust state-of-the-art CART manufacturing processes.
• Execute and analyze Design of Experiments (DoE) studies to support process understanding optimization and characterization activities.
• Support clinicalscale nonGMP manufacturing operations for execution of BLAenabling process characterization activities.
• Support and contribute to process characterization efforts and continuous improvement initiatives aimed at enhancing CART manufacturing processes and capabilities (e.g. evaluation of process parameters materials closed or disposable systems and operational workflows).
• Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.
• Ensure high-quality timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
• Present data/strategy to scientists (and management) in internal venues (technical meetings Project Team meetings) as appropriate.
• Remain current with relevant cell therapy immunology and bioprocessing literature.
• Other duties as assigned

Requirements:

• BS in Chemical Engineering Biochemistry Molecular & Cell Biology Immunology or related field with at least 2 years of relevant experience required.
• A demonstrated foundational understanding of mammalian or primary cell culture biochemistry molecular & cell biology and immunology (required for enhanced product & process understanding).
• Experience with prior Gene & Cell Therapy manufacturing preferred but not required.
• Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion and cryopreservation preferred.
• Experience in genetic modification of cells using gene edit and gene delivery technologies preferred but not required.
• Experience in flow cytometry for T cells characterization preferred but not required.
• Experience in FMEA process characterization and DOE methodologies in biologics or cell therapy space preferred.
• Ability to work in a fast-paced startup environment.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• 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 and provide a top-notch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected hourly range for this role is $40 to $45 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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